Patrick A. Jordan 3112 Ridgestone Parkway p.l.jordan1999@gmail.com Durham, NC 27712

(C) (919)257-8983

Professional Experience Therapeutic experience in IVD, Oncology, Hematology, Orthopedics, GI, Cardiology, Melanoma,

ENT, Multiple Sclerosis, and ADHD Extensive knowledge of FDA regulations, ICH guidelines, GLPs, GCPs, and SOPs Monitoring experience of national and international sites for PSSVs, SIVs, IMVs, and COVs Ability to identify issues and resolve appropriately

Experience in multiple EDC systems and platforms

Professional Experience Clinical Operations Health Decisions 01/2016-07/2016 CRA

Therapeutic Areas: Women’s Health – Contraceptive device, IVD, and Neonatal preterm birth

Phases: III

● Responsible for CRA duties for commercially funded protocols – medical device and IVD (in vitro

diagnostic device) involving national sites

● Perform monitoring visits - PSSV, SIV, IMV, and COV

● Ensure the integrity of clinical data and adherence to applicable FDA regulations, ICH guidelines, and

protocols

● Ensure that the rights, safety, and well-being of clinical trial subjects are maintained

● Collaborate with the Core Project Team and site staff to drive subject recruitment

● Prepare all monitoring documentation/reports for assigned protocols as required

● Establish and maintain effective contact with internal and external personnel (primary point of contact

for site staff)

● Responsible for maintaining knowledge applicable to the protocol, indication, and job performance

Clinical Operations Rho, Inc. 10/2014-09/2015 CRA I

Therapeutic Areas: ENT, Multiple Sclerosis, Rheumatoid Arthritis, and ADHD (Pediatrics)

Phases: III

● Responsible for CRA duties for federally and commercially funded protocols involving national and

international sites

● Performed monitoring visits - SQV, SIV, IMV, and COV

● Ensured the integrity of clinical data and adherence to applicable FDA regulations, ICH guidelines,

and protocols

● Ensured that the rights, safety, and well-being of clinical trial subjects are maintained

● Collaborated with the Core Project Team and site staff to drive subject recruitment

● Prepared all monitoring documentation/reports for assigned protocols as required

● Established and maintained effective contact with internal and external personnel (primary point of

contact for site staff)

● Responsible for maintaining knowledge applicable to the protocol, indication, and job performance

DCRI Duke University Medical Center 03/2014-07/2014 CRA II

Therapeutic Areas: Antibacterial resistance

Phases: I-II

● Lead on PSSVs for three (3) clinical trials involving 104 potential worldwide sites

● Performed site feasibility and site selection documentation for ARLG protocols

● Maintained all ARLG Site Trackers for all active and upcoming ARLG protocols

● Primary point of contact for sites and vendors

● Wrote guidelines and SOPs for ARLG protocols and international sites

Ockham Contractor at Quintiles 12/2013-03/2014 CTA

Therapeutic Areas: Gastrointestinal disorders

Phases: III

● Lead CTA team for two (2) Purdue studies as well as controlling access for all electronic systems (EDC,

CTMS, ordering, materials, and IP) for both internal and external customers

● Updated and prepared the compliance, performance, and timeline matrix

● Prepared, distributed, filed, and archived clinical documentation

● Performed QA/QC review of study files

● Distributed Clinical Trial Supplies to sites

● Controlled and maintained access for all electronic systems for internal and external customers

Pinnacle Technology Contractor at BectonDickinson 07/2013-08/2013

CRA II (Short Contract)

Therapeutic Areas: Women’s Health (OB/GYN)

Phases: I-II

● Successfully completed contracted objective in half the time allotted

● Performed CRA responsibilities for 3 protocols and multiple sites

● Prepared all monitoring documentation/reports for assigned protocols as required

● Performed monitoring visits such as site evaluation, SIV, IMV, and COV

● Facilitated the distribution of supplies, equipment, and study materials to the sites.

● Re-trained site staff and management for adherence to protocol

● Regularly attends and participates in project team meetings

● Performed QA/QC on FDA regulatory documentation for protocols

Aerotek Contractor at bioMerieux 01/2013-07/2013 Clinical Scientist (Short Contract)

Therapeutic Areas: Melanoma – detection and treatment, Medical device, and IVD

Phases: III-IV

● Instrumental involvement in two (2) successful IVD product PMA approvals during contract ● Responsible for weekly meetings with the Bio partners – GSK and Novartis ● Responsible for clinical operations of site set-up, equipment, and training

● Performed CRA responsibilities for 3 protocols - IVD (in vitro diagnostic device) - and multiple domestic and international sites

● Monitor and problem solve reference laboratories to ensure compliance with FDA regulations, ICH guidelines, and GLP

● Active liaison between partnership sites and reference laboratories maintaining positive working relationships to obtain the desired goals

● Responsible for site staff PCR (IVD BRAF) Proficiency certification and oversight ● Performed QA/QC on FDA regulatory documentation for protocols

Department of Medicine-Hematology Duke University Medical Center 2008-2013 Clinical Research Coordinator II

Therapeutic Areas: Clotting/Bleeding disorders, Cardiothoracic surgery, HIT, Orthopedics, and GI

Phases: III

● National leader in patient recruitment in all assigned protocols

● Performed In-house monitoring duties for satellite sites (Mayo Clinic, University of Wisconsin, UNC,

and VA Hospitals) for multi-year NIH funded/sponsored cardiothoracic clinical trial

● Developed, plan, and implement clinical trial protocols with principal investigators, staff, multiple

departments, and outside vendors

● Coordinate all aspects of the clinical trial from presentations to closure of the trial ● Screen, recruit, and collect desired deliverables for protocol ● Recruitment responsibilities for institutional, industry/pharma, and federal clinical trials ● Trained various other sites and cardiology groups with enrollment strategies ● Lectured and lead break out group at several national PI/CRC meetings for recruitment strategies ● Performed QC/QA on assigned protocols

PRMO/Clinical Trials Duke University Health System 2006-2008 Patient Account Analyst

● Analyzed and performed QA/QC on all research for all DUHS centers

● Researched all aspects of an account from date to ICD9 codes ● QA accounts in Hyland Onbase from the CRSO/CTBO team ● Performed charge move transactions as necessary for compliance and completeness ● Investigate accounts and coordinate changes to accounts/clinical trial grids with CRSO/CTBO team

members and external customers ● Recorded quality and performance of CRSO/CTBO team members ● Performed. daily reports ● Trained personnel inside the clinical trial department

Operations/QC J & G Exteriors, LLC 1997-2006

Project Manager

Developed and oversaw all proposals, contracts, accounting, and logistical methods

Developed and maintained internal and external relationships Managed projects from proposal through completion Maintained good customer service practices and policies Developed and trained all personnel Performed QA/QC on all projects

Analyzed and implemented policies and procedures to ensure efficiency and achievement of company goals

Marketing and Sales Ventana Medical Systems 1993-1997 Technical Marketing Representative-Southeast Region

Therapeutic Areas: Cancer Research, Immunohistochemistry, and IVD (in vitro diagnostic

device)

Phases: I-III

• Developed, coordinated, and implemented nationwide oncology and in-situ research in Jacksonville

Memorial Women's Cancer Center, Duke University Cancer Center, NIH, Armed Forces Institute of Pathology, University of Colorado Cancer Center, University of Arizona Medical Center, and Cleveland Clinic.

• Developed and implemented technical and safety training for all the hospital laboratory accounts in

the Southeast region • Responsible for QA/QC and training of staff in all of the laboratories • Developed protocols and training to achieve all national testing accreditation (CAP, JCAHO, etc.) • Maintained all necessary national certifications • Organized and instructed seminars on local, regional, and national levels

Cell Imaging Lab Duke Cancer Center 1986-1993

Laboratory Technologist

Therapeutic Areas: Cancer Research, Immunohistochemistry

Phases: I-III

Developed cancer tissue bank and implemented clinical trials for prognostic/diagnostic markers

Developed and coordinated research projects with principal investigators

Responsible for all aspects of the immunohistochemistry laboratory Performed QC/QA, safety, and training for all of staff

Analyzed, organized, and discussed data of research projects with principal investigators Coordinated and collaborated on the submission of manuscripts for publication

Public Safety City of Durham 1981-1986

Public Safety Officer

Class II NC certified law enforcement officer Class II Nationally certified firefighter

Responsible for the protection and safety of the citizens of Durham

Responsible for the enforcement of the state, county, and city laws

Durham training instructor for the Academy and squad C Certified instructor in Firearms, high risks situation, and defensive tactics

Education

Candidate for Masters of Clinical Research (2017), Campbell University, Buies Creek, NC Bachelor of Science 1982, Business Administration/Math, Wingate College, Wingate, NC