Theresa Kwabbi
@theresakwabbi
Clinical Research Associate focused on TMF, site management, and ICH-GCP compliance to ensure trial success.
United StatesWhat I'm looking for
I’m a dedicated Clinical Research Associate with 3 years of progressive experience in clinical trial execution and site management across Phase I-IV studies. I serve as a primary liaison for clinical sites, safeguarding human subject rights and well-being while ensuring data integrity and compliance with protocols, ICH-GCP, and regulatory requirements.
In my previous roles, I’ve coordinated qualification, initiation, and maintenance monitoring visits across 20+ clinical sites per study and managed Trial Master File (TMF) documentation across 5+ studies to achieve 95% inspection readiness and reduce filing discrepancies. I also review and reconcile regulatory and essential documents to verify 100% compliance with ICH-GCP and FDA guidelines, partner with cross-functional teams to resolve issues, and lead site training initiatives that improved protocol adherence and reduced protocol deviations across 20+ sites.
Experience
Work history, roles, and key accomplishments
Served as primary liaison for clinical sites, coordinating qualification, initiation, and maintenance monitoring across 20+ clinical sites per study to support activation and enrollment readiness for Phase I-IV trials. Managed TMF documentation across 5+ studies, achieving 95% inspection readiness, resolving study issues with cross-functional teams, and maintaining 100% compliance with ICH-GCP and
Supported clinical trial execution from setup through close-out across 15+ sites, assisting with start-up activities, regulatory submissions, and study maintenance while maintaining TMF documentation for audit and milestone readiness. Monitored enrollment trends and tracked CRF completion, query resolution, and safety reporting to support timely, compliant study execution.
Assisted study teams and site staff with document reconciliation and collection across 10+ sites, ensuring 100% trial compliance. Supported vendor access and training compliance verification, addressed site issues (inquiries and documentation gaps), and applied CRO SOPs, study procedures, and ICH-GCP guidelines to day-to-day operations.
Education
Degrees, certifications, and relevant coursework
University of Georgia
Bachelor of Science, Biology
2017 - 2021
Earned a Bachelor of Science in Biology from the University of Georgia (Athens), completing the program from 2017 to 2021.
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
Interested in hiring Theresa?
You can contact Theresa and 90k+ other talented remote workers on Himalayas.
Message TheresaFind your dream job
Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!
