John D. Peterson
Clinical Research
Moorhead,MN
Summary
Clinical research professional with strong background in coordinating complex projects and ensuring compliance with regulatory standards. Adept at fostering team collaboration and driving results in fast-paced environments. Skilled in project management, data analysis, and effective communication. Known for reliability and adaptability in meeting changing needs and achieving project goals.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Project Coordinator
Oregon Health & Science University
02.2023 - 07.2025
- Coordinated a multi-center clinical trial across five US Level One Trauma Centers, overseeing study implementation, site training, and protocol adherence; accelerated study start-up within two months, overcoming a six-year delay.
- Ensured regulatory compliance at five trauma centers, coordinating with the FDA, central and local IRBs, and the Department of Defense (DoD).
- Partnered with the OHSU Data Coordinating Center to produce monthly and quarterly reports for key stakeholders, including the DoD and DSMB.
- Managed a $15 million budget, establishing subcontracts for each participating site.
- Co-managed the Investigational Product, designing and constructing 30 drug kits with three distinct configurations.
- Kept projects on schedule by managing deadlines and adjusting workflows.
Project Manager, Client Services
ProPharma Group
05.2021 - 06.2022
- Delivered clinical pharmacovigilance project management services to over 20 clients daily, reducing a two-month deliverable backlog to a daily/weekly turnaround.
- Conducted weekly client meetings to monitor project progress, providing timely updates.
- Supervised a team of five Client Services members, outsourcing clinical Pharmacovigilance services, globally.
- Developed, reviewed, and finalized Pharmacovigilance Agreements (PVA), SAE Report Forms, and Argus Setup documents with other departments.
- Supported clients in drafting Statements of Work (SOWs) and managing Change Orders for ongoing studies.
- Led monthly invoicing, coordinating across departments with accounting and client service teams.
Director, Quality and Compliance
Verified Clinical Trials
06.2019 - 12.2021
- Directed the Quality Assurance program to ensure compliance with legal, regulatory, and guidance standards.
- Transitioned the company's documentation from a paper-based to a secure digital system within three months.
- Maintained audit readiness through regular self-audits, client and vendor audits, and virtual audit hosting.
- Oversaw CAPA (Corrective and Preventive Action) resolution and closure processes.
- Ensured continuous alignment of company policies with regulatory changes in online privacy and quality standards.
Sr. Director, Clinical Trial Operations
AXIS Clinicals
01.2016 - 08.2018
- Directed clinical trial operations, including resource allocation, client relations, adverse event reviews, budget management (from $100K to $2M), and volunteer management, ensuring compliance with GCP and ICH guidelines.
- Launched a 'Fast to File' program, recruiting 144 volunteers across four studies in two weeks for FDA submissions.
- Collaborated daily with the medical writing team in India, contributing to protocol development, consent forms, statistical reports, and risk assessments.
- Managed a team of 17 interdisciplinary members, providing mentorship, overseeing task execution, vendor management, and timeline adherence.
Associate Director, Clinical Trial Services
AXIS Clinicals
02.2015 - 01.2016
- Led recruitment initiatives, supervising the recruitment services department.
- Hired eight employees, including strategy development, interviewing, selection, onboarding, and training.
- Enhanced volunteer recruitment through website improvements, social media outreach, and participation in community events, increasing the volunteer database from 5,000 to 15,000.
- Partnered with study physicians on scheduling, study feasibility, patient assessments, and payroll management.
- Developed budget plans and marketing strategies, achieving a 98% clinical trial fill rate.
- Championed the implementation of the VCT duplicate study subject detection system to improve process efficiency.
Independent Consultant
Lachman Consultant Services
05.2013 - 11.2015
- Delivered solutions for pharmaceutical companies by extracting data, supporting bioanalysis, and drafting responses to investigational product and FDA deficiency letters from the closed PRACS Institute.
- Developed a comprehensive matrix cataloging all versions of company SOPs spanning over 30 years and three different corporate entities.
- Played a key role in the destruction and redistribution of investigational products accumulated over three decades, coordinating efforts with the DEA, North Dakota State Board of Pharmacy, and the FDA.
- Frequently deployed to East Coast clinical sites to conduct reviews of clinical documents, clinical data, and Trial Master Files (TMFs).
Clinical Specialist, Clinical Trial Operations
AXIS Clinicals
09.2014 - 02.2015
Coordinator / Associate Director
PRACS Institute
04.1999 - 03.2013
Education
Doctor of Pharmacy - Pharmacy
North Dakota State University
Fargo, ND1998
Bachelor of Science - Pharmaceutical Sciences
North Dakota State University
Fargo, ND1996
Skills
- Clinical trial management
- Site selection
- Adverse event reporting
- Investigator relations
- Document management
Certification
Certified Clinical Research Coordinator (CCRC), ACRP
Languages
English
Native or Bilingual
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Project Coordinator
Oregon Health & Science University
02.2023 - 07.2025
Project Manager, Client Services
ProPharma Group
05.2021 - 06.2022
Director, Quality and Compliance
Verified Clinical Trials
06.2019 - 12.2021
Sr. Director, Clinical Trial Operations
AXIS Clinicals
01.2016 - 08.2018
Associate Director, Clinical Trial Services
AXIS Clinicals
02.2015 - 01.2016
Clinical Specialist, Clinical Trial Operations
AXIS Clinicals
09.2014 - 02.2015
Independent Consultant
Lachman Consultant Services
05.2013 - 11.2015
Coordinator / Associate Director
PRACS Institute
04.1999 - 03.2013
Doctor of Pharmacy - Pharmacy
North Dakota State University
Bachelor of Science - Pharmaceutical Sciences
North Dakota State University
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