Experienced Study Start-Up Coordinator

Medpace, Inc.•Cincinnati, OH

6d•Onsite

About The Position

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinators to join our Study Start-up team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. We have openings for clinical research coordinators to best match your experience level. If you want to build on your foundational knowledge and your previous experience to develop and grow your career even further, then this is the opportunity for you.

Requirements

Bachelor's degree 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