clinical projects associate 46 873-cpa-w
TRANSCRIPT
Should you be interested in the above position and wish to apply, please send your application with your CV,
quoting the above reference number, to our recruitment team at [email protected]
CTC Resourcing Solutions, 117 Waterloo Road, SE1 8UL, London, UK Tel.: +44 207 193 9972 www.ctcresourcing.com [email protected]
Providing Flexible Resourcing Solutions CTC Resourcing Solutions, founded 1997, is a pan-European specialist staffing organisation with offices in London, Basel and Munich, providing flexible resourcing solutions to the pharmaceutical industry across Europe, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing For a key client, we are currently looking for a:
Clinical Projects Associate Reference Number: 46-873-CPA-W Type of placement: Permanent Location: Oxfordshire, UK Our client is an entrepreneurial drug discovery and drug development company focused on breakthrough treatments for unmet needs across a range of disease areas. Located in Oxfordshire and with compounds currently in early phase trials, our client has recently strategically refocused the Company on the development of its high value clinical stage assets. The objective is to add value to its programmes by advancing them through to important clinical milestones at which time the Company will seek to partner the programmes. As part of this strategy the company is seeking to hire an experienced Clinical Projects Associate who will support clinical project teams in all phases of the planning, execution and analysis of outsourced clinical trials. Purpose: Responsible for supporting the Clinical Project Teams administratively in all phases of the planning, conduct and analysis of clinical trials and associated regulatory activities. Performs work under general supervision Main Responsibilities:
Assists with preparation of all external and internal documentation, for assigned trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol, under close supervision
Assists Clinical Project Manager in site management activities which could include review of monitoring report, tracking of site visits, communication with monitors and sites, and other activities as assigned
Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and Case Report Forms
Assists the Clinical Project Manager in ensuring compliance with Clinical Study Protocol and provides timely updates to assigned Clinical Project Manager to confirm compliance
Organises and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established guidelines
Maintains updates and may establish databases for clinical tracking.
Maintains files and inventories of chemicals, supplies and equipment and tracks delivery and receipt of required supplies and materials to study sites
Prepares materials for, and may attend, investigator meetings
Participates in project meetings
Follows Standard Operating Procedures
Generate and distribute regulatory packages
Process and track payments to vendors and study sites as appropriate
Support planning and logistics for meetings including investigator meetings, meetings with CROs and other vendors.
Should you be interested in the above position and wish to apply, please send your application with your CV,
quoting the above reference number, to our recruitment team at [email protected]
CTC Resourcing Solutions, 117 Waterloo Road, SE1 8UL, London, UK Tel.: +44 207 193 9972 www.ctcresourcing.com [email protected]
Performs other duties as assigned
Demonstrates a working knowledge of ICH GCP regulations and clinical protocols Qualifications and Experience:
Educated to degree level or equivalent in a relevant scientific field
Previous experience of working in a clinical environment
Demonstrable experience of SOP’s, ICH, GCP
Ability to interact successfully with both internal and external stakeholders at all levels
Strong computer skills
Ability to independently solve routine problems following standard policies/procedures
Detail oriented with excellent organisational and interpersonal skills
A dynamic self-starter in tune with the demands and constraints of working in a small company
Good communicator in all ways
Strong team player
Experience of working in a clinical research role for a UK pharma / biotech / CRO is essential Our offer:
Competitive basic salary
Discretionary Bonus
Benefits package o Contributory pension o Life assurance o Private health o Share option plan
28 days holiday