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Clinical Trial Associate
Clinical ResearchRemote (EST)Full TimeReports to Head of Clinical Trial Compliance
About the Role
The Clinical Trial Associate is a critical core team member responsible for the successful planning, implementation, and execution of contracted clinical trial activities. You will support the study team, including meeting minutes, preparing project updates, and metrics/KPI tracking. You will assist with TMF reviews. This is a cross-functional position, working regularly with clinical, legal, finance, regulatory affairs, quality assurance, and IT, as needed while also being external facing towards our clients.
What You'll Do
- Coordinate regulatory document collection and review
- Provide oversight of Trial Master File set-up, ongoing quality review, and final reconciliation of study documents, including review of site regulatory documents/packages
- Develop and maintain site/monitoring tools and trackers
- Prepare project updates and dashboards in collaboration with the project manager
- Review and identify trends, including enrollment, data entry, and protocol deviations
- Contribute to the development of detailed project plans, including timelines, milestones, and resource allocation
- Ensure compliance with SOPs, contract terms, system requirements, and metrics
- Support preparation of study-related documents, including protocols, informed consent forms, and study reports
- Develop and track project budgets, assist in revenue projections, and propose/implement cost-effective solutions
Qualifications
- B.S. with minimum 2 years of experience; scientific or healthcare degree preferred
- Experience overseeing regulatory documents, TMF management, and study compliance
- Ability to track study progress, analyze trends, and deliver project updates
- Experience supporting study documentation, planning, and budget tracking across teams
- Strong organizational and communication skills
- Ability to work cross-functionally across clinical, legal, finance, regulatory, QA, and IT teams
How to Apply
Send your resume and a brief note about your experience in clinical trial operations.
Apply NowPi Health is an equal opportunity employer.