- Aid in clinical study planning and execution, working closely with Study Managers in adherence of GCPs, SOPs, FDA regulations, and ICH guidelines
- Provide clinical trial management support to teams while tracking CRO and vendor performance relating to project goals and milestones to the company oversight plan.
- Work with TMF document trackers provided by the CRO to bring reconciliation issues to the attention of Study Managers
- Distribute and provide study documents to vendors.
- Administer clinical support to teams (preparing meeting agendas, minutes, meeting with research organizations and investigators)
- Coordinate with regulatory operations to report information on public forums
- Review CRO reports, maintain monitoring spreadsheet and visit information. Elevate issues to the supervisor.
- Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor.
- Analyze site metrics to identify areas of concern
- Knowledge of processes related to clinical studies, regulatory issues, CRO operations, and compliance practices
- Interact with internal and external stakeholders
- Foundational knowledge of complex compliance practices
- Manage information, data, related analyses, forms and reports
- Supports and multi-tasks complex assignments and responsibilities.
- Identifies and resolves problems when able to, escalates issues appropriately
- Familiarity with medical terminology.
- Bachelor's degree- Life Sciences
- Relevant clinical development experience in lieu of degree is acceptable.
- CRA experience is preferred.
- Clinical research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO).
- Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant