Study Start-Up Coordinator
| Company | Medpace, Inc. |
|---|---|
| Location | Cincinnati, OH, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- A minimum of a Bachelor’s degree is required (preferably in a Life Sciences field)
- 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry specializing in study start-up is required
- Excellent organizational and prioritization skills
- Knowledge of Microsoft Office
- Great attention to detail and excellent oral and written communication skills
Responsibilities
- Communicate with research sites (doctor’s offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial
- Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF)
- Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB)
- Maintain timelines for study 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
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges
Preferred Qualifications
-
No preferred qualifications provided.