Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Research Coordinator (internally called Regulatory Submissions Coordinator) to join our Clinical Operations team. This position plays a key role in the clinical trial management and study start-up process at Medpace. We have openings ranging from entry to senior coordinator to best match your experience level. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
- Communicate with research sites (doctor’s offices, universities, hospitals, etc.) regarding the distribution and review of site essential documentation;
- Maintain and perform quality review of trial documents within the Trial Master File (TMF);
- Collect, review, organize, and assemble regulatory start-up submissions (includes submissions to Institutional Review Boards, or IRB);
- Maintain timelines for site start-up through both internal and external collaboration;
- Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements; and
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
- A minimum of a Bachelor’s degree is required (preferably in a Life Sciences field);
- Some experience in an office setting is preferred for entry candidates; and
- 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry is required for experienced candidates;
- Excellent organizational and prioritization skills;
- Knowledge of Microsoft Office; and
- Great attention to detail and excellent oral and written communication skills.