Study Start-Up Coordinator, PharmD

About the Role

Medpace is seeking full-time, office-based Regulatory Submissions Coordinators to join their Study Start-up team. This role plays a key part in clinical trial management and study start-up. The position is described as entry-level, offering a robust training program for career development.

Key Responsibilities

• Communicate with research sites to collect essential documents before patient screening begins.
• Maintain and perform quality reviews 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 internal and external collaboration.
• Review regulations and guidance to develop solutions for regulatory issues and challenges.

SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAM

• Complete independent learning modules, interactive exercises, and team workshops.
• Gain exposure to real-world tasks through a mentoring program.
• Collaborate with professionals to advance clinical trials.

Requirements & Tech Stack

• PharmD required.
• 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