- Collect, process, and track serious adverse event (SAE) reports
- Generate safety narratives and queries
- Safety Database data entry
- Perform quality control of safety cases
- Generate Investigator Safety Letters
- SAE reconciliation between safety database and clinical database
- TMF uploads and quality control review
- Preparation of Clinical Safety documents as required (i.e., safety management plan, periodic safety reports and presentations)
- Attending internal and external meetings, as required (including sponsor TCs and audits/inspections)
- Leading clinical trial projects (ensure client deliverables are met, provide oversight and compliance reports)
Additional Responsibilities
- Develop presentation material and present during face-to-face Sponsor meetings (i.e., Kick-off Meetings, Investigator Meetings)
- Coordinate final medical review of study report narratives and submission to Medical Writers
- Develop drafts of adjudication material (i.e., charter, reporting materials)
- Provide periodic safety summaries to project Data Manager, Clinical Trial Manager, and Medical Monitor
- Train new Clinical Safety Coordinators on safety reporting responsibilities
- Coordinate safety responsibilities for aggregate reporting purposes (e.g., ensure timely data entry, tracking of pending cases, collaborate with Medical Monitor and Regulatory Affairs)
- Bachelor’s life science degree
- Working knowledge of Safety Databases (Argus is desirable)
- Demonstrate advanced knowledge of medical terminology, global safety reporting requirements and Good Clinical Practice (GCP) Guidelines
- Exposure to working on global trails as part of a multidisciplinary team
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- Hybrid work-from-home options (dependent upon position and level)
- Competitive PTO packages
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Flexible work schedule
- Competitive compensation and benefits package
- Structured career paths with opportunities for professional growth
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next