Study Start-Up Coordinator, PhD
Medpace
Cincinnati, OHFresher1h agovia LinkedIn
About the Role
- This position plays a key role in the clinical trial management and study start-up process.
- Works both independently and collaboratively to meet common goals.
- Office-based role.
Key Responsibilities
- Communicate with research sites to collect all essential documents required before patient screening begins.
- 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.
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAM
- Completes independent learning modules, interactive exercises, and team workshops through the core curriculum.
- Gains exposure to real-world tasks through a robust mentoring program.
- Joins other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.
Requirements & Tech Stack
- PhD required (Life Sciences field preferred).
- Some experience in an office setting is preferred.
- Excellent organizational and prioritization skills.
- Knowledge of Microsoft Office.
- Great attention to detail.
- Excellent oral and written communication skills.
Travel
- None