contents€¦ · job role scientist clinical research and development role description the...

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h Contents 1. Introduction and Contacts..….……….…….P.1 2. Qualifications Pack……….………………........P.2 3. Glossary of Key Terms ….……………..........P.4 4. NOS Units………………………..….……..………..P.6 5. Annexure: Nomenclature for QP and OS..P.45 6. Assessment Criteria……………………………….P.47 OS describe what individuals need to do, know and understand in order to carry out a particular job role or function OS are performance standards that individuals must achieve when carrying out functions in the workplace, together with specifications of the underpinning knowledge and understanding New Delhi E-mail: Qualifications Pack-Scientist Clinical Research and Development SECTOR: LIFE SCIENCES SUB-SECTOR: PHARMACEUTICAL AND BIOPHARMACEUTICAL OCCUPATION: RESEARCH & DEVELOPMENT REFERENCE ID: LFS/Q0507 ALIGNED TO: NCO-2004/NIL Scientist Clinical Research and Developments is responsible for planning and directing studies to investigate about the disease, preventive methods, and treatments for the same. Brief Job Description: Scientist Clinical Research and Development plans and directs studies to investigate human or animal disease, preventive methods and treatment for diseases while carrying out functions such as investigation, support in clinical trials, analysis of clinical data, supervision etc. Personal Attributes: The individual should have good knowledge of standard documentation procedures, rules, regulations and statutory requirements in carrying out research and development. The individual must demonstrate attention to detail and proactive behaviour. The individual should be well versed with the drugs used in the investigation studies. Introduction QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY

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Page 1: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

h

Contents 1. Introduction and Contacts..….……….…….P.1

2. Qualifications Pack……….………………........P.2

3. Glossary of Key Terms ….……………..........P.4

4. NOS Units………………………..….……..………..P.6

5. Annexure: Nomenclature for QP and OS..P.45

6. Assessment Criteria……………………………….P.47

technology consul t ing

OS describe what

individuals need to do, know and understand in order to carry out a particular job role or function

OS are

performance standards that individuals must achieve when carrying out functions in the workplace, together with specifications of the underpinning knowledge and understanding

New Delhi E-mail:

Qualifications Pack-Scientist Clinical Research and

Development

SECTOR: LIFE SCIENCES

SUB-SECTOR: PHARMACEUTICAL AND BIOPHARMACEUTICAL

OCCUPATION: RESEARCH & DEVELOPMENT

REFERENCE ID: LFS/Q0507

ALIGNED TO: NCO-2004/NIL

Scientist Clinical Research and Developments is responsible for planning and directing studies to investigate about the disease, preventive methods, and treatments for the same.

Brief Job Description: Scientist Clinical Research and Development plans and directs studies to investigate human or animal disease, preventive methods and treatment for diseases while carrying out functions such as investigation, support in clinical trials, analysis of clinical data, supervision etc.

Personal Attributes: The individual should have good knowledge of standard documentation procedures, rules, regulations and statutory requirements in carrying out research and development. The individual must demonstrate attention to detail and proactive behaviour. The individual should be well versed with the drugs used in the investigation studies.

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Introduction

QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY

Page 2: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

Qualifications Pack For Scientist Clinical Research and Development

2 | P a g e

Qualifications Pack Code

LFS/Q0507

Job Role Scientist Clinical Research and Development

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Sub-sector

Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation R&D Next review date 01/08/19

NSQC Clearance on 20/07/2015

Job Role Scientist Clinical Research and Development

Role Description

The Scientist Clinical Research and Development plans and directs studies to investigate disease, preventive methods and treatment for diseases while carrying out functions such as investigation, clinical trials, analysis of clinical data, supervision etc.

NSQF level Minimum Educational Qualifications Maximum Educational Qualifications

6

Master’s degree in pharmaceutical, biotechnology, nursing or life sciences/ M. Pharma. /M.Sc. in the above disciplines

Doctorate in pharmaceutical, biotechnology, nursing or life sciences/ MBBS/ MD (Pharmacology)

Training (Suggested but not mandatory)

On the job training

Minimum Job Entry Age 27 Years

Experience

Minimum of 5 years of experience in clinical drug development or in the pharmaceutical/ life sciences industry

Applicable National Occupational Standards (NOS)

Compulsory: 1. LFS/N0522: Carry out investigation

2. LFS/N0523: Supervise and guide laboratory personnel

3. LFS/N0524: Conduct analysis and interpretation of data

Job

Det

ails

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Qualifications Pack For Scientist Clinical Research and Development

3 | P a g e

Page 4: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

Qualifications Pack For Scientist Clinical Research and Development

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4. LFS/N0102: Carry out reporting and documentation

5. LFS/N0101: Maintain a healthy, safe and secure working

environment in the life sciences sector

6. LFS/N0525: Assist in research activities

7. LFS/N0526: Work with cross functional teams for carrying

out research activities

8. LFS/N0527: Conduct clinical trials

Optional:

N.A.

Performance Criteria As described in the relevant NOS units

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Qualifications Pack For Scientist Clinical Research and Development

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Keywords /Terms Description

Core Skills/Generic Skills

Core Skills or Generic Skills are a group of skills that are key to learning and working in today's world. These skills are typically needed in any work environment. In the context of the NOS, these include communication related skills that are applicable to most job roles.

Description Description gives a short summary of the unit content. This would be helpful to anyone searching on a database to verify that this is the appropriate NOS they are looking for.

Function

Function is an activity necessary for achieving the key purpose of the sector, occupation, or area of work, which can be carried out by a person or a group of persons. Functions are identified through functional analysis and form the basis of NOS.

Job role

Job role defines a unique set of functions that together form a unique employment opportunity in an organisation.

Knowledge and Understanding

Knowledge and Understanding are statements, which together specify the technical, generic, professional and organisational specific knowledge that an individual needs in order to perform to the required standard.

National Occupational Standards (NOS)

NOS are Occupational Standards, which apply, uniquely in the Indian context.

Occupation

Occupation is a set of job roles, which perform similar/related set of functions in an industry.

Organisational Context

Organisational Context includes the way the organisation is structured and how it operates, including the extent of operative knowledge managers have of their relevant areas of responsibility.

Performance Criteria

Performance Criteria are statements that together specify the standard of performance required when carrying out a task.

Qualifications Pack(QP)

Qualifications Pack comprises the set of NOS, together with the educational, training and other criteria required to perform a job role. A Qualifications Pack is assigned a unique qualification pack code.

Qualifications Pack Code

Qualifications Pack Code is a unique reference code that identifies a qualifications pack.

Scope

Scope is the set of statements specifying the range of variables that an individual may have to deal with in carrying out the function which have a critical impact on the quality of performance required.

Sector Sector is a conglomeration of different business operations having similar businesses and interests. It may also be defined as a distinct subset of the economy whose components share similar characteristics and interests.

Def

init

ion

s

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Qualifications Pack For Scientist Clinical Research and Development

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Sub-Sector Sub-sector is derived from a further breakdown based on the characteristics and interests of its components.

Sub-functions

Sub-functions are sub-activities essential to fulfil the achieving the objectives of the function.

Technical Knowledge

Technical Knowledge is the specific knowledge needed to accomplish specific designated responsibilities.

Unit Code

Unit Code is a unique identifier for an NOS unit, which can be denoted with an ‘N’.

Unit Title

Unit Title gives a clear overall statement about what the incumbent should be able to do.

Vertical

Vertical may exist within a sub-sector representing different domain areas or the client industries served by the industry.

Keywords /Terms Description

NOS National Occupational Standard(s)

NSQF National Skill Qualifications Framework

NCO-2004 National Classification of Occupations-2004

OS Occupational Standard(s)

QP Qualifications Pack Acr

on

yms

Page 7: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

LFS/N0522 : Carry out investigation

7 | P a g e

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Scientist Clinical Research and Development to carry out investigational studies.

National Occupational

Standards

Page 8: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

LFS/N0522 : Carry out investigation

8 | P a g e

Unit Code LFS/N0522

Unit Title (Task)

Carry out investigation

Description This NOS is about a Scientist Clinical Research and Development performing the required activities to effectively carry out investigational studies.

Scope

The unit/ task covers the following: 1. Examining organs, tissues, fluids or cells 2. Performing moderate and high complexity laboratory tests

Performance Criteria (PC) w.r.t. the Scope

Element

Performance Criteria

Examining organs, tissues, fluids or cells.

To be competent, the user/individual on the job must be able to: PC1. examine and analyze at microscopic, chemical and molecular level the body

fluids and cells to look for bacteria, parasites, and other microorganisms. PC2. inoculate cultures carefully needed to identify bacteria. PC3. analyze the chemical reactions to determine concentrations of compounds

such as blood glucose and cholesterol levels. PC4. identify blood groups and cross matching blood for transfusions. PC5. monitoring the effects of medication by testing how a patient is responding to

treatment. PC6. perform tests in all sections of the laboratory including

haematology,bacteriology,chemistry,urinalysis,serology,immunohematology,for

ensicpathology,immunology,and toxicology.

Performing moderate

and high complexity

laboratory tests

PC7. ensure the conditions required for the maintenance of sample. PC8. perform some non-automated and specialized laboratory procedures. PC9. follow set procedures to deal with contingencies arising during

i nvestigations. PC10. determine the presence of normal or abnormal components by

physical examination, laboratory testing and through diagnostic

imaging techniques including radiography and ultrasound.

PC11. testing of samples using molecular diagnostics and highly involved microbiological and cross-matching blood tests.

PC12. identify factors which may prevent or alter specific disease. PC13. identify types and uses of vaccines in the prevention of infection. PC14. develop and implement new tests and methodologies as required.

A. Organisational Context (Knowledge of the Company/ Organisation and

The user/individual on the job needs to know and understand:

KA1. chemicals used in the industry and their function.

KA2. personal protection (which protective equipment to be used and how).

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LFS/N0522 : Carry out investigation

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its processes) KA3. the levels of hygiene required by workplace and importance of maintaining the same.

KA4. availability and use of monitoring and measuring devices. KA5. implications of inaccurate measuring and testing. KA6. implications (impact on internal/external customers)of defective

products, materials or components.

B. Technical Knowledge

The user/individual on the job needs to know and understand: KB1. the basic structure and functions of the integumentary,

skeletal,muscular,nervous,endocrine,cardiovascular,lymphatic,respiratory,digestive,urinary,and reproductive systems.

KB2. tests to be conducted on samples and related handling and preparation requirements and responsibilities.

KB3. the cells, their development, identification and functions and the microscopic examination of blood films.

KB4. characteristics of materials sampled and common contaminants and related conditions under which contamination is likely to occur.

KB5. the basic concepts of transfusion science, including the application of genetics and immunology to transfusion practice.

KB6. major blood group systems, antibody detection and identification procedures.

KB7. role of different materials, chemicals and equipment. KB8. testing equipment and related test methods and purpose of tests. KB9. calibration procedure for test equipment. KB10. standard method of drawing samples and preparing them for testing. KB11. methods/techniques used for labeling samples. KB12. procedure to be followed in case the sample is unfit for testing. KB13. national/international standard test methods for different compounds. KB14. the methods that can be used for controlling test variables. KB15. factors that adversely affect integrity of the sample. KB16. knowledge of high-resolution functional magnetic resonance imaging MRI

equipment; Medical magnetic resonance imaging MRI equipment.

KB17. procedures for chemical analysis of body fluids as per organizational protocol.

KB18. procedures for the reporting of abnormal constituents in body fluids to the

right concerned person as per the organizational policy

Skills (S)

A. Core Skills/ Generic Skills

Writing skills

The user/ individual on the job needs to know and understand how to: SA1. record and communicate details of work done to appropriate people using

written/typed report or computer based record/electronic mail write detailed reports for investigation.

SA2. maintain proper and concise records as per given format.

Reading skills

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LFS/N0522 : Carry out investigation

10 | P a g e

The user/individual on the job needs to know and understand how to: SA3. read and understand manuals, SOPs, health and safety instructions, memos,

reports, job cards etc. SA4. read images, graphs, diagrams. SA5. understand the various coding systems as per company norms.

Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA6. communicate confidential and sensitive information discretely to authorized

person as per SOP

SA7. listen effectively

B. Professional Skills

Decision Making

The user/individual on the job needs to know and understand how to: SB1. evaluate multiple options on defined, objective parameters SB2. appropriately use the escalation matrix for complex decisions

Critical Thinking

The user/individual on the job needs to know and understand how to: SB3. apply balanced judgement to different situations SB1. apply, analyse and evaluation information to define action steps

Plan & Organize

The user/individual on the job needs to know and understand how to: SB4. plan and organize investigation as per deadlines

Analytical Skills

The user/individual on the job needs to know and understand how to: SB5. identify, define and resolve problems using a structured methodology SB6. suggest improvements(if any) in process based on experience

Problem Solving

NA

Customer Centricity

NA

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LFS/N0522 : Carry out investigation

11 | P a g e

NOS Version Control

NOS Code LFS/N0522

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Industry Sub-sector Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation R&D Next review date 01/08/19

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LFS/N0526 : Work with cross-functional teams for carrying out research activities

12 | P a g e

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Scientist Clinical Research and Development to effectively work with cross functional teams.

National Occupational

Standards

Page 13: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

LFS/N0526 : Work with cross-functional teams for carrying out research activities

13 | P a g e

Unit Code LFS/N0526

Unit Title (Task)

Work with cross functional teams for carrying out research activities

Description This NOS unit is about a Scientist Clinical Research and Development working with cross functional teams.

Scope

The unit/ task covers the following: 1. Working effectively with others.

Performance Criteria (PC) wrt the Scope

Element

Performance Criteria

Working effectively with others

To be competent, you must be able to:

PC1. working effectively with other people who can be part of the immediate team, organization or external to the team or organization to meet requirements.

PC2. sharing information with others to enable efficient delivery of work. PC3. communicating with other team members and people internal or external to

the organization. PC4. provide and receive support and feedback from others in the team. PC5. work with biostatistician, scientists in the other field and from different regions

collaboratively to develop study design and pursue research further.

Knowledge and Understanding (K)

A. Organisational Context (Knowledge of the Company/ Organisation and its processes)

You need to know and understand: KA1. strong understanding of quality systems and procedures. KA2. risk and impact of not following defined procedures/work instructions . KA3. types of documentation in organization, importance of maintaining the same

and different methods of recording information . KA4. impact of various practices on cost, quality, productivity, delivery and safety . KA5. procedures for reporting any unresolved issues and hazards. KA6. reporting incidents where standard operating procedures are not followed . KA7. the knowledge about the appropriate authority for reporting any imbalances.

B Technical Knowledge

You need to know and understand: KB1. knowledge on different standard reference material . KB2. use of Computer/application software .

Skills (S)

Writing skills

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Page 14: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

LFS/N0526 : Work with cross-functional teams for carrying out research activities

14 | P a g e

A. Core Skills/ Generic Skills

The user/ individual on the job needs to know and understand how to: SA1. record and communicate details of work done to appropriate people using

written/typed report SA2. communicate with supervisor and team members data/ information/ support/

advice needed

Reading skills

The user/individual on the job needs to know and understand how to: SA3. read and interpret written data/information/ communication carefully

Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA4. be clear and precise in communication SA5. listen effectively SA6. maintain confidentiality of information and data

B. Professional Skills

Critical Thinking

The user/individual on the job needs to know and understand how to:

SB1. apply balanced judgement to different situations SB2. provide sound, constructive, objective opinion

Plan and Organize

The user/individual on the job needs to know and understand how to:

SB3. work effectively with cross-functional team members across multiple functions, locations and hierarchy level

SB4. establish rapport and effective working relationships with business partners, department leadership and peers

Decision Making

The user/individual on the job needs to know and understand how to: SB5. act objectively when faced with difficult/stressful or emotional situations SB6. appropriately use the escalation matrix for complex team decisions SB7. collaborate with the team for taking decisions

Problem Solving

The user/individual on the job needs to know and understand how to:

SB8. apply problem solving approaches to different situations SB9. solve conflicts within the team

Analytical Thinking

NA

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LFS/N0526 : Work with cross-functional teams for carrying out research activities

15 | P a g e

Customer Centricity

NA

NOS Version Control

NOS Code LFS/N0526

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Industry Sub-sector Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation R&D Next review date 01/08/19

Page 16: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

LFS/N0527 : Conduct clinical trials

16 | P a g e

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Scientist Clinical Research and Development to effectively conduct clinical trials.

National Occupational

Standards

Page 17: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

LFS/N0527 : Conduct clinical trials

17 | P a g e

Unit Code LFS/N0527

Unit Title (Task)

Conduct clinical trials

Description This NOS unit is about a Scientist Clinical Research and Development to conduct clinical trials.

Scope

The unit/task covers the following: 1. Conduct pre-clinical studies. 2. Performing clinical trials.

Performance Criteria (PC) wrt the Scope

Element

Performance Criteria

Conduct pre-clinical studies

To be competent, you must be able to: PC1. conduct in vitro i.e. test tube or cell culture experiments. PC2. conduct in vivo i.e. animal experiments. PC3. use wide-ranging doses of the study drug to obtain preliminary efficacy,

toxicity and pharmacokinetic information. PC4. assess whether a drug candidate has scientific merit for further development as an

investigational new drug.

Performing Clinical Trials

PC5. establish the dose range tolerated by volunteers for single and for multiple doses

PC6. conduct all the phases of clinical trial. PC7. gather preliminary data on the pharmacodynamics (what the drug does to the

body)and pharmacokinetics(what the body does to the drugs). PC8. assessthesafety(pharmacovigilance),tolerability,pharmacokinetics,andpharmac

odynamicsofadrug. PC9. determine a safe dose range. PC10. identify and monitor side-effects of the drug. PC11. provide regulatory submission i.e. comprehensive description of the methods

and results of human and animal studies, manufacturing procedures, formulation details, and shelf life for review to the appropriate regulatory authorities.

PC12. detect any rare or long-term adverse effects over a much larger patient population

and longer time period.

Knowledge and Understanding (K)

B. Organisational Context (Knowledge of the Company/ Organisation and its processes)

You need to know and understand: KA1. the principles and processes to provide patient care, including patient need

assessment, meeting quality standards for services, and evaluation of customer satisfaction.

KA2. material disposal procedure, importance of appropriate disposal of material and implications of not following the material disposal procedure.

KA3. risk and impact of not following defined procedures/work instructions. KA4. reporting incidents where standard operating procedures are not followed. KA5. the importance of complete and accurate documentation. KA6. the importance of quality control procedures.

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LFS/N0527 : Conduct clinical trials

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KA7. measures, steps and possible solutions that have been taken/identified to address the previous problems.

KA8. the correct method for carrying out corrective actions outlined for each problem.

KA9. usage of LIMS(Laboratory information management system).

B Technical Knowledge

You need to know and understand: KB1. the basic structure and functions of the integumentary, skeletal, muscular,

nervous,endocrine,cardiovascular,lymphatic,respiratory,digestive,urinary,and reproductive systems.

KB2. tests to be conducted on samples and related handling and preparation requirements and responsibilities.

KB3. the cells, their development, identification and functions and the microscopic examination of blood films.

KB4. knowledge on different standard reference material. KB5. testing equipment and related test methods and purpose of tests. KB6. calibration procedure for test equipment. KB7. sampling techniques relevant to samples collected, such as sterilization

methods and procedures.

KB8. procedures and responsibility for reporting and recording sampling information, such as legislative requirements.

KB9. the process of undertaking sterilization of the unit. KB10. the chemical composition, structure, and properties of substances and of the

chemical processes and transformations that they undergo including the use

ofchemicalsandtheirinteractions,dangersigns,productiontechniques,and disposal

methods.

KB11. evaluate the likely success of an idea in relation to the demands of the situation.

KB12. conduct all the phases of clinical trial.

KB13. use of wide range of drugs on the subject.

Skills (S)

A. Core Skills/ Generic Skills

Writing Skills

The user/individual on the job needs to know and understand how to:

SA1. record and communicate details of work done to appropriate people using written/typed report or computer based record/electronic mail write detailed reports for investigation.

SA2. maintain proper and concise records as per given format

SA3. maintain confidentiality of information and data

Reading skills

The user/individual on the job needs to know and understand how to: SA4. read and understand manuals, SOPs, health and safety instructions, memos,

reports, job cards etc.

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LFS/N0527 : Conduct clinical trials

19 | P a g e

SA5. read images, graphs, diagrams. SA6. understand the various coding systems as per company norms.

Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA7. disclose information only to those who have the right and need to know it. SA8. communicate confidential and sensitive information discretely to authorized

person as per SOP.

B. Professional Skills

Analytical Thinking

The user/individual on the job needs to know and understand how to: SB1. pay attention to detail when handling equipment/apparatus SB2. suggest improvements(if any) in protocol execution SB3. spot process disruptions and delays in protocol execution and report and

communicate with solutions

Critical Thinking

The user/individual on the job needs to know and understand how to: SB7. apply balanced judgement to different situations SB4. apply, analyse and evaluation information to define protocol execution action steps

Problem Solving

The user/individual on the job needs to know and understand how to: SB5. explore new ways of doing things SB6. think through problems, evaluate the possible solutions and suggest an optimum

solution, including identify immediate or temporary solutions to resolve delays

Decision Making

The user/individual on the job needs to know and understand how to: SB8. evaluate multiple options on defined, objective parameters SB9. collaborate with the team for taking decisions

Plan & Organize

The user/individual on the job needs to know and understand how to: SB10. plan and organize assigned work in order to achieve specified targets and deadlines

of the clinical trials SB11. effectively interact with the various stakeholders in the clinical trial process

Customer Centricity

NA

Page 20: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

LFS/N0527 : Conduct clinical trials

20 | P a g e

NOS Version Control

NOS Code LFS/N0527

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Industry Sub-sector Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation R&D Next review date 01/08/19

Page 21: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

LFS/N0524 : Conduct analysis and interpretation of data

21 | P a g e

Overview

This Occupational Standard describes the knowledge, understanding and skills required of a Scientist Clinical Research and Development to conduct analysis and interpretation of data.

National Occupational

Standards

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LFS/N0524 : Conduct analysis and interpretation of data

22 | P a g e

Unit Code LFS/N0524

Unit Title (Task)

Conduct analysis and interpretation of data

Description This NOS unit is about conducting analysis and interpretation of data by the Scientist Clinical Research and Development.

Scope

This Unit/task covers the following: 1. Different methodology to analyse data by applying the principles and

processes of statistical analysis.

2. Report writing based on the analysis.

Performance Criteria (PC) w.r.t. the Scope

Element

Performance Criteria

Different methodology to analyse data by applying the principles and processes of statistical analysis

To be competent, the user/individual on the job must be able to: PC1. identify the appropriate analytical process to be used to analyze the data and

consult with relevant people, gathering all the data relevant to the analysis PC2. prepare the statistical analysis plan, which describes the proposed analysis in

detail. PC3. ensure the presence of the data and information required to perform the

analysis. PC4. collate all the data required for the analysis. PC5. review the data and information to select the methodology required to analyze

the data. PC6. performing quality checks on the data accordance with organizational

policies and procedures. PC7. compile the results of the analyze and check for any variances in the data. PC8. report any variances to the appropriate people and deal with them in

accordance with organizational policies and procedures. PC9. carryout statistical and graphical methods to present the results of the analysis.

Report writing based on the analysis.

PC10. carryout the report writing within the agreed timeline. PC11. issue the report, requesting feedback from the agreed people reviewing the report. PC12. ensure that amendments are made in line with organizational policies and

procedures. PC13. issue the final report to the relevant personnel.

Knowledge and Understanding (K)

A. Organisational Context (Knowledge of the Company/ Organisation and its processes)

The user/individual on the job needs to know and understand: KA1. escalation matrix for reporting identified issues, hazards and breakage. KA2. types of documentation in organization, importance of maintaining the same

and different methods of recording information. KA3. the reason and impact of the occurrence of problems. KA4. measures, steps and possible solutions that have been taken/identified to

address the previous problems. KA5. usage of LMIS(Laboratory information management system).

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B. Technical Knowledge

The user/individual on the job needs to know and understand: KB1. knowledge on different standard reference material.

KB2. statistical analysis of test data. KB3. use of Computer/application software. KB4. knowledge about SAS program. KB5. knowledge of process information by compiling, coding, categorizing, calculating,

tabulating, auditing or verifying data.

Skills (S)

A. Core Skills/ Generic Skills

Writing skills

The user/ individual on the job needs to know and understand how to: SA1. record details of work done to using written/typed report or computer based

record/electronic mail SA2. maintain proper and concise records as per given format SA3. prepare analysis and trend observation reports

Reading skills

The user/individual on the job needs to know and understand how to: SA4. read data/ information /notes/comments gathered from stakeholders SA5. communicate confidential and sensitive information discretely to authorized person SA6. read information on databases

Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA7. communicate effectively with the team members and supervisors SA8. communicate confidential and sensitive information discretely to authorized person

as per SOP

B. Professional Skills

Analytical thinking

The user/individual on the job needs to know and understand how to: SB1. suggest improvements(if any) in process/formats for reports/documentation based

on experience and observation SB2. analyse gathered information and data for trends identification SB3. apply statistical and computer skills Critical Thinking

The user/individual on the job needs to know and understand how to: SB4. apply balanced judgement for interpreting data analysis results SB5. provide sound, constructive, objective opinion

Plan and Organise

The user/individual on the job needs to know and understand how to:

SB6. effectively plan and allocate work amongst team members SB7. take responsibility for completing one’s own work assignment

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SB8. plan and prioritize work basis criticality and urgency

Problem Solving

NA

Decision Making

NA

Customer Centricity

NA

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NOS Version Control

NOS Code LFS/N0524

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Industry Sub-sector Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation R&D Next review date 01/08/19

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LFS/N0102 : Carry out reporting and documentation

26 | P a g e

Overview

This Occupational Standard describes the knowledge, understanding and skills required of a Scientist CRD for reporting and recording of data/problem/incidents etc. and to maintain information security.

National Occupational

Standards

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LFS/N0102 : Carry out reporting and documentation

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Unit Code LFS/N0102

Unit Title (Task)

Carry out reporting and documentation

Description This NOS is about a Scientist CRD for reporting ,recording and documentation of data/problem/incidents etc. and to maintain information security

Scope

The unit covers the following:

1. Reporting of data/problem/incidents etc.

2. Recording and documentation 3. Information security

Performance Criteria (PC) w.r.t. the Scope

Element

Performance Criteria

Reporting of data/problem/incidents etc.

To be competent, the user/individual on the job must be able to: PC1. report data/problems/incidents as applicable in a timely manner

PC2. report to the appropriate authority as laid down by the company

PC3. follow reporting procedures as prescribed by the company

Recording and Documentation

PC4. identify documentation to be completed relating to one’s role

PC5. record details accurately in an appropriate format

PC6. complete all documentation within stipulated time according to company

procedure

PC7. ensure that the final document meets regulatory and compliance

requirements

PC8. make sure documents are available to all appropriate authorities to inspect

Information Security PC9. respond to requests for information in an appropriate manner whilst

following organizational procedures

PC10. inform the appropriate authority of requests for information received

Knowledge and Understanding (K)

A. Organisational Context (Knowledge of the Company/ Organisation and its processes)

The user/individual on the job needs to know and understand: KA1. types of documentation in organization, importance of maintaining the same

and different methods of recording information

KA2. reporting incidents where standard operating procedures are not followed

KA3. the importance of complete and accurate documentation

KA4. knowledge of production workflow sequences and materials demand

KA5. escalation matrix for reporting identified issues, hazards and breakage

B. Technical Knowledge

The user/individual on the job needs to know and understand:

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KB1. obtain and interpret records, charts, specifications, equipment manuals, history/technical support reports and other documents

Skills (S)

A. Core Skills/ Generic Skills

Writing skills

The user/ individual on the job needs to know and understand how to: SA1. record and communicate details of work done to appropriate people using

written/typed report SA2. maintain proper records as per given format

Reading skills

The user/individual on the job needs to know and understand how to: SA3. read and understand manuals, SOPs, health and safety instructions, memos,

reports, job cards etc. SA4. ability to read and interpret images, graphs, diagrams for typical product

specifications, job sheets, procedures, basic machine control panels, material labels and safety information as provided

SA5. understand the various coding systems as per company norms

Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA6. disclose information only to those who have the right and need to know it. SA7. communicate confidential and sensitive information discretely to

authorized person as per SOP SA8. communicate with people in a form and manner and using language that is

open and respectful

B. Professional Skills

Analytical Thinking

The user/individual on the job needs to know and understand how to: SB1. attention to detail SB2. use of automated report writing and documentation technologies

Critical Thinking

The user/individual on the job needs to know and understand how to: SB3. suggest improvements(if any) in process based on experience

Plan and Organise

The user/individual on the job needs to know and understand how to:

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SB4. capacity and skill to learn from experience in a range of settings and scenarios and the capacity to reflect on and analyze one’s learning.

Problem Solving

The user/individual on the job needs to know and understand how to: SB5. act objectively , rather than impulsively or emotionally when faced with

difficult/stressful or emotional situations

Decision Making

NA

Customer Centricity

NA

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NOS Version Control

NOS Code LFS/N0102

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Industry Sub-sector Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation R&D Next review date 01/08/19

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LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility

31 | P a g e

National Occupational

Standards

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Scientist CRD to ensure healthy, safe and secure working environment in the life sciences facility.

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LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility

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Unit Code LFS/N0101

Unit Title (Task)

Maintain a healthy, safe and secure working environment

Description This NOS is about a Scientist CRD monitoring the working environment and making sure that it meets the requirements for health, safety and security in the pharmaceutical/contract research/biopharmaceutical facility/manufacturing/testing/analysis/research laboratory.

Scope

The unit/task covers the following: Ensuring healthy, safe and secure working environment:

Self-monitor and adhere to safety principles and standards and report any identified breaches in health, safety, and security policies and procedures to the designated person

Identify and recommend opportunities for improving health, safety, and security to the designated person

Managing emergency procedures:

Illness

Accidents

Fires

Other reasons to evacuate the premises

Breaches of security

Performance Criteria (PC) w.r.t. the Scope

Element

Performance Criteria

Ensuring healthy, safe and secure working

environment

To be competent, the user/individual on the job must be able to carry out: Ensuring healthy, safe and secure working environment: PC1. observe and comply with your company’s current health, safety and security

policies and procedures

PC2. while carrying out work, use appropriate safety gears like head gear, masks,

gloves and other accessories as mentioned in the guidelines

PC3. report any identified breaches in health, safety, and security policies and

procedures to the designated person

PC4. responsible for maintaining discipline at the shop-floor area

PC5. identify and correct any hazards that you can deal with safely, competently and

within the limits of your authority

PC6. adhere and comply to storage and handling guidelines for hazardous material

PC7. identify and recommend opportunities for improving health, safety, and

security to the designated person

PC8. complete any health, safety and security records legibly and accurately

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Managing

emergency

procedures

PC9. report any hazards that you are not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected PC10. follow your company’s emergency procedures promptly, calmly, and efficiently

Knowledge and Understanding (K)

A. Organisational Context (Knowledge of the Company/ Organisation and its processes)

The user/individual on the job needs to know and understand: KA1. legislative requirements and company’s procedures for health, safety and

security and your role and responsibilities in relation to this

KA2. what is meant by a hazard, including the different types of health and safety

hazards that can be found in the workplace

KA3. how and when to report hazards

KA4. limits of your responsibility for dealing with hazards

KA5. your organization’s emergency procedures for different emergency situations

and the importance of following these

KA6. the importance of maintaining high standards of health, safety and security

KA7. implications that any non-compliance with health, safety and security

may have on individuals and the organization

KA8. health hazards and its implications if any in the production process

B. Technical Knowledge

The user/individual on the job needs to know and understand: KB1. different types of breaches in health, safety and security and how and when to

report these

KB2. evacuation procedures for workers and visitors

KB3. how to summon medical assistance and the emergency services, where

necessary

KB4. how to use the health, safety and accident reporting procedures and the

importance of these

KB5. different types of occupational health hazards

KB6. knowledge of chemical substances, their characteristics and required

precaution and safety measures

Skills (S)

A. Core Skills/ Generic Skills

Writing Skills

The user/ individual on the job needs to know and understand how to: SA1. report/observation writing skills

Reading Skills

The user/individual on the job needs to know and understand how to: SA2. read notes/comments from the supervisor SA3. read job sheets and interpret technical details mentioned in the jobsheet

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Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA4. interact with team members to work efficiently

B. Professional Skills

Decision Making

The user/individual on the job needs to know and understand how to: SB1. spot and communicate potential areas of disruptions to work process and

report the same SB2. when to report to supervisor and when to deal with a colleague individually,

depending on the type of concern

Problem Solving

The user/individual on the job needs to know and understand how to: SB3. improve work processes by interacting with others and adopting best practices

Critical Thinking

The user/individual on the job needs to know and understand how to: SB4. spot process disruptions and delays and report and communicate with solutions

Analytical Thinking

NA

Plan and Organize

NA

Customer Centricity

NA

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NOS Version Control

NOS Code LFS/N0101

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Industry Sub-sector Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation R&D Next review date 01/08/19

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LFS/N0523 : Supervise and guide laboratory personnel

36 | P a g e

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Scientist Clinical Research and Development to supervise and guide laboratory personnel.

National Occupational

Standards

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LFS/N0523 : Supervise and guide laboratory personnel

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Unit Code LFS/N0523

Unit Title (Task)

Supervise and guide laboratory personnel

Description This NOS unit is about a Scientist Clinical Research and Development to supervise and guide laboratory personnel.

Scope

The unit/ task covers the following:

Managing a laboratory.

Supervising, training and/or directing other laboratory personnel.

Performance Criteria (PC) wrt the Scope

Element

Performance Criteria

Managing a laboratory

To be competent, you must be able to: PC1. inspect equipment, structures, or materials to identify the cause of errors or

other problems or defects. PC2. generate or use different sets of rules for combining or grouping things in

different ways. PC3. ensure the relevant policies and procedures followed in the organization.

PC4. report any variances to the appropriate people and deal with them in

accordance with organizational policies and procedures.

Supervising, training and/or directing other laboratory personnel.

PC5. supervising, training and/ or directing laboratory technicians, assistants, or

other medical laboratory workers engaged in laboratory testing.

PC6. deal with people at junior levels to effectively direct their work towards optimum output.

PC7. analyse the training needs of the laboratory personnel’s. PC8. select and prepare training and instruction resources to deliver the activities. PC9. training the laboratory personnel’s on the Good Laboratory Practice;GLP. PC10. guiding the laboratory personnel’s on the new automated laboratory

techniques. PC11. monitor and refine training activities to improve the trainee's attainment of

required scientific or technical skills. PC12. supervising the team of laboratory personnel’s in carrying out advanced

testing and in dealing with highly automated equipment. PC13. communicating with other team members and people internal or external to

the organization.

Knowledge and Understanding (K)

A. Organisational Context (Knowledge of the Company/ Organisation and its processes)

You need to know and understand: KA1. different quality management systems (ISO-9000,TS16949,ISO-14001,OHSAS-

18000),good laboratory and manufacturing practices.

KA2. risk and impact of not following defined procedures/work instructions.

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KA3. measures, steps and possible solutions that have been taken/identified to address the previous problems.

KA4. the correct method for carrying out corrective actions outlined for each problem.

B Technical Knowledge

You need to know and understand: KB1. role of different materials, chemicals and equipment.

KB2. knowledge of hazardous material and dealing with disasters, if any.

Skills (S)

A. Core Skills/ Generic Skills

Writing Skills

The user/ individual on the job needs to know and understand how to: SA1. report/observation writing skills SA2. record and communicate details of work done to appropriate people using

written/typed report or computer based record/electronic mail SA3. maintain proper and concise records as per given format

Reading skills

The user/individual on the job needs to know and understand how to: SA4. follow guidelines/procedures/rules and service level agreements SA5. read notes/comments from supervisors and stakeholders SA6. disclose information only to those who have the right and need to know it

Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA7. communication with upstream and downstream teams SA8. listen effectively and orally communicate information accurately SA9. communicate confidential and sensitive information discretely to authorized

person as per SOP

B. Professional Skills

Decision making

The user/individual on the job needs to know and understand how to: SB1. make decisions on a suitable course of action or response

Plan and Organise

The user/individual on the job needs to know and understand how to: SB2. plan work assigned on a daily basis and provide estimates of time required for each piece of work

Analytical Skills

The user/individual on the job needs to know and understand how to: SB3. attention to details SB4. analyse data and activities SB5. pass on relevant information to members and supervisors SB6. identify and share improvements

Problem Solving

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39 | P a g e

The user/individual on the job needs to know and understand how to: SB7. seek clarification on problems from supervisors SB8. use effective problem solving techniques

Critical thinking

The user/individual on the job needs to know and understand how to: SB9. provide opinions on work in a detailed and constructive way SB10. apply balanced judgments to different approaches Customer Centricity

NA

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LFS/N0523 : Supervise and guide laboratory personnel

40 | P a g e

NOS Version Control

NOS Code LFS/N0523

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Industry Sub-sector Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation R&D Next review date 01/08/19

Page 41: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

LFS/N0525 : Assist in research activities

41 | P a g e

National Occupational

Standards

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Scientist CRD to assist in research activities.

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LFS/N0525 : Assist in research activities

42 | P a g e

Unit Code LFS/N0525

Unit Title (Task)

Assist in research activities

Description This NOS is about a Scientist Clinical Research and development assisting in research activities.

Scope

The unit/task covers the following: 1. Developing new techniques.

Performance Criteria (PC) w.r.t. the Scope

Element

Performance Criteria

Developing new techniques

PC1. take necessary approval from the authorities before undertaking research. PC2. ensure that research follows the standard. PC3. identify information by categorizing, estimating, recognizing differences or

similarities, and detecting changes in circumstances or events. PC4. combine pieces of information to form general rules or conclusions

(includes finding a relationship among seemingly unrelated events). PC5. apply general rules to specific problems to produce answers that make sense PC6. concentrate on a task over a period of time without being distracted. PC7. understand the need and importance of research and the protocols for conducting

the same.

Knowledge and Understanding (K)

B. Organisational Context (Knowledge of the Company/ Organisation and its processes)

The user/individual on the job needs to know and understand: KA1. the importance of quality control procedures. KA2. characteristics of the product/material. KA3. knowledge of research techniques KA4. knowledge of data sources

B. Technical Knowledge

The user/individual on the job needs to know and understand: KB1. the correct method for carrying out corrective actions outlined for each

problem.

KB2. knowledge on different standard reference material.

KB3. role of different materials, chemicals and equipment. KB4. national/international standard test methods for different compounds.

KB5. knowledge of process information by compiling, coding, categorizing,

calculating, tabulating, auditing or verifying data.

KB6. evaluate the likely success of an idea in relation to the demands of the

situation.

KB7. knowledge and experience in hypothesis creation and data validation

activities

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Skills (S)

A. Core Skills/ Generic Skills

Writing skills

The user/ individual on the job needs to know and understand how to: SA1. make complete and accurate notes of the information and data gathered SA2. read, write and speak in English SA3. report writing and documentation skills

Reading skills

The user/individual on the job needs to know and understand how to: SA4. follow guidelines/procedures/rules and service level agreements SA5. read and interpret formulas and images, if any

Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA6. interact with people to effectively gather information SA7. listen effectively and orally communicate information accurately SA8. ask for clarification and advice from others

B. Professional Skills

Decision Making

The user/individual on the job needs to know and understand how to: SB1. make decisions on a suitable course of action or response

Plan and Organise

The user/individual on the job needs to know and understand how to: SB2. plan work assigned on a daily basis and provide estimates of time required for

each piece of work SB3. ability to delegate work as per the strengths of individuals SB4. complete work within the proposed deadlines

Problem Solving

The user/individual on the job needs to know and understand how to: SB5. seek clarification on problems from supervisors SB6. use effective problem solving techniques

Analytical Thinking

The user/individual on the job needs to know and understand how to: SB7. analyse data and activities

SB8. pass on relevant information to members and supervisors SB9. identify and share improvements SB10. use of computer/application software SB11. use of quality management system/procedures SB12. attention to detail Critical Thinking

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44 | P a g e

The user/individual on the job needs to know and understand how to: SB13. provide opinions on work in a detailed and constructive way SB14. apply balanced judgments to different approaches Customer Centricity

NA

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LFS/N0525 : Assist in research activities

45 | P a g e

NOS Version Control

NOS Code LFS/N0525

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Industry Sub-sector Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation R&D Next review date 01/08/19

Page 46: Contents€¦ · Job Role Scientist Clinical Research and Development Role Description The Scientist Clinical Research and Development plans and directs studies to investigate disease,

Qualification pack for Scientist Clinical Research and Development

46 | P a g e

Annexure

Nomenclature for QP and NOS

Qualification Pack

9 characters

LFS/ Q 0101

LFS QP Number (2 numbers)

Q denoting Qualification Pack Occupation (2 numbers)

Occupational Standard

An example of NOS with ‘N’

9 characters

LFS/ N 0101

LFS OS Number (2 numbers)

Occupation (2 numbers)

N denoting National Occupational Standard

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Qualification pack for Scientist Clinical Research and Development

47 | P a g e

The following acronyms/codes have been used in the nomenclature above:

Sub-Sector Range of Occupation Numbers

Pharmaceutical and Biopharmaceutical and Contract Research

01-10

Pharmaceutical 11-20

Biopharmaceutical 21-30

Contract Research 31-40

Sequence Description Example

Three letters Industry name LFS

Slash / /

Next letter Whether QP or NOS Q//N

Next two numbers Occupation code 01

Next two numbers OS number 01

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Qualification pack for Scientist Clinical Research and Development

48 | P a g e

CRITERIA FOR ASSESSMENT OF TRAINEES

Job Role Scientist Clinical Research and Development Qualification Pack LFS/Q0507 Sector Skill Council Life Sciences Sector Skill Development Council

Guidelines for Assessment: 1. Criteria for assessment for each Qualification Pack will be created by the Sector Skill Council. Each Performance Criteria (PC) will be assigned marks proportional to its importance in NOS. SSC will also lay down proportion of marks for Theory and Skills Practical for each PC. 2. The assessment for the theory part will be based on knowledge bank of questions created by the SSC. 3. Individual assessment agencies will create unique question papers for theory part for each candidate at each examination/training center (as per assessment criteria below) 4. Individual assessment agencies will create unique evaluations for skill practical for every student at each examination/training center based on this criteria 5. To pass the Qualification Pack , every trainee should score a minimum of 70% in every NOS 6. In case of successfully passing only certain number of NOS's, the trainee is eligible to take subsequent assessment on the balance NOS's to pass the Qualification Pack.

Marks Allocation

Assessment Outcome

Assessment Criteria of Outcomes Total Marks (800)

Out Of Theory Skills

Practical

LFS/N0522 (Carry out

investigation)

PC1. examine and analyze at microscopic, chemical and molecular level the body fluids and cells to look for bacteria, parasites, and other microorganisms.

100

10 5 5

PC2. inoculate cultures carefully needed to identify bacteria

10 4 6

PC3. analyze the chemical reactions to determine concentrations of compounds such as blood glucose and cholesterol levels

10 4 6

PC4. monitoring the effects of medication by testing how a patient is responding to treatment

10 3 7

PC5. perform tests in all sections of the laboratory including haematology,bacteriology,chemistry,urinalysis,serology,immunohematology,forensicpathology,immunology,and toxicology

10 4 6

PC6. ensure the conditions required for the maintenance of sample

5 2 3

PC7. perform some non-automated and specialized laboratory procedures

5 2 3

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Qualification pack for Scientist Clinical Research and Development

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PC8. follow set procedures to deal with contingencies arising during investigations

5 2 3

PC9. identify blood groups and cross matching blood for transfusions

5 2 3

PC10. determine the presence of normal or abnormal components by physical examination, laboratory testing and through diagnostic imaging techniques including radiography and ultrasound

10 4 6

PC11. testing of samples using molecular diagnostics and highly involved microbiological and cross-matching blood tests

5 2 3

PC12. identify factors which may prevent or alter specific disease

5 2 3

PC13.identifytypesand uses of vaccines in the prevention of infection

5 2 3

PC14.develop and implement new tests and methodologies as required

5 2 3

Total 100 40 60

LFS/N0527 (Conduct clinical

Trials)

PC1. conduct in vitro i.e. test tube or cell culture experiments

100

10 4 6

PC2. conduct in vivo i.e. animal experiments

10 4 6

PC3. use wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information

8 4 4

PC4. assess whether a drug candidate has scientific merit for further development as an investigational new drug

8 3 5

PC5. establish the dose range tolerated by volunteers for single and for multiple doses

8 4 4

PC6. conduct all the phases of clinical trial

8 4 4

PC7. gather preliminary data on the pharma co dynamics (what the drug does to the body)and pharmacokinetics(what the body does to the drugs)

8 4 4

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PC8. assess the safety( pharma co vigilance), tolerability, pharma co kinetics, and pharma co dynamics of a drug

8 3 5

PC9. determine a safe dose range 8 4 4

PC10. identify and monitor side-effects of the drug

8 3 5

PC11. provide regulatory submission i.e. Comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life for review to the appropriate regulatory authorities

8 4 4

PC12. detect any rare or long-term adverse effects over a much larger patient population and longer time period

8 4 4

Total 100 45 55

LFS/N0524 (Conduct analysis and interpretation

of data)

PC1. identify the appropriate analytical process to be used to analyze the data and consult with relevant people, gathering all the data relevant to the analysis

100

10 5 5

PC2. prepare the statistical analysis plan, which describes the proposed analysis in detail

10 4 6

PC3. ensure the presence of the data and information required to perform the analysis

5 2 3

PC4. collate all the data required for the analysis

8 4 4

PC5. review the data and information to select the methodology required to analyze the data

10 5 5

PC6. performing quality checks on the data accordance with organizational policies and procedures

5 2 3

PC7. compile the results of the analyze and check for any variances in the data

10 5 5

PC8. report any variances to the appropriate people and deal with them in accordance with organizational policies and

6 3 3

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procedures

PC9. carryout statistical and graphical methods to present the results of the analysis

10 4 6

PC10. carryout the report writing within the agreed timeline

10 4 6

PC11. issue the report, requesting feedback from the agreed people reviewing the report

5 2 3

PC12. ensure that amendments are made in line with organizational policies and procedures

5 2 3

PC13. issue the final report to the relevant personnel

6 3 3

Total 100 45 55

LFS/NO523 (Supervise and

guide laboratory personnel)

PC1. inspect equipment, structures, or materials to identify the cause of errors or Other problems or defects

100

8 3 5

PC2. Generate or use different sets of rules for combining or grouping things in Different ways

8 4 4

PC3. ensure the relevant policies and procedures followed in the organization

8 4 4

PC4. report any variances to the appropriate people and deal with them in accordance with organizational policies and procedures

7 3 4

PC5. supervising, training and/ or directing laboratory technicians, assistants, or other medical laboratory workers engaged in laboratory testing.

8 3 5

PC6. deal with people at junior levels to effectively direct their work towards Optimum output

8 4 4

PC7. analyse the training need of laboratory personnel

7 3 4

PC8. selectand prepare training and instruction resources to deliver the activities

8 4 4

PC9. training laboratory personnel on GLP

8 4 4

PC10. guiding laboratory personnel on new automated laboratory techniques

8 4 4

PC11. monitor and refine training 8 3 5

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activities to improve the trainee's attainment of required scientific or technical skills

PC12. supervising the team of laboratory personnel in carrying out advanced Testing and in dealing with highly automated equipment

7 3 4

PC13. communicating with other team members and people internal or external to the organization

7 3 4

Total 100 45 55

LFS/N0525 (Assist in research

activities)

PC1. Take necessary approval from the authorities before undertaking research

100

12 6 6

PC2. ensure that research follows the standard

12 6 6

PC3. Identify information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events

20 8 12

PC4. combine pieces of information to form general rules or conclusions(includes finding a relationship among seemingly unrelated events)

20 8 12

PC5. apply general rules to specific problems to produce answers that make sense

12 4 8

PC6. concentrate on a task over a period of time without being distracted

12 4 8

PC7. understand the need and importance of research and the protocols for conducting the same

12 4 8

Total 100 40 60

LFS/N0526 (Work with cross functional teams for carrying out

research activities)

PC1. Working effectively with other people who can be part of the immediate team, organization or external to the team or organization To meet requirements

100

16 8 8

PC2. sharing information with others to enable efficient delivery of work

20 10 10

PC3. communicating with other team members and people internal or external to the organization

20 10 10

PC4. provide and receive support and feedback from others in the team

20 10 10

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PC5. work with bio statistician, scientists in the other field and from different regions collaboratively to develop study design and pursue research further.

24 12 12

Total 100 50 50

LFS/N0102 ( Carry out

reporting and documentation)

PC1. report data/problems/incidents as applicable in a timely manner

100

10 5 5

PC2. report to the appropriate authority as laid down by the company

10 5 5

PC3. follow reporting procedures as prescribed by the company

10 5 5

PC4. identify documentation to be completed relating to one’s role

10 5 5

PC5. record details accurately in an appropriate format

10 5 5

PC6. complete all documentation within stipulated time according to company procedure

10 5 5

PC7. ensure that the final document meets regulatory and compliance requirements

10 5 5

PC8. make sure documents are available to all appropriate authorities to inspect

10 5 5

PC9. respond to requests for information in an appropriate manner whilst following organizational procedures

10 5 5

PC10. inform the appropriate authority of requests for information received

10 4 6

Total 100 49 51

LFS/N0101 Maintain a safe,

healthy and secure working

environment

PC1. observe and comply with your company’s current health, safety and security policies and procedures

10 5 5

PC2. while carrying outwork, use appropriate safety gears like head gear, masks, gloves and other accessories as mentioned in the guidelines

10 5 5

PC3. report any identified breaches in health, safety, and security policies and procedures to the designated person

10 5 5

PC4. responsible for maintaining discipline at the shop-floor/production area

10 5 5

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PC5. identify and correct any hazards that you can deal with safely, competently and within the limits of your authority

10 5 5

PC6. adhere and comply to storage and handling guidelines for hazardous material

10 5 5

PC7. identify and recommend opportunities for improving health, safety, and security to the designated person

10 5 5

PC8. complete any health, safety and security records legibly and accurately

10 4 6

PC9. report any hazards that you are not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected

10 4 6

PC10. follow your company’s procedures promptly, calmly and efficiently.

10 5 5

Total 100 48 52