Study Start-Up Coordinator (CRC Experience)

Medpace, Inc.•Cincinnati, OH

1d•Onsite

About The Position

Our clinical operations activities are growing rapidly, and we are currently seeking talent Clincial Research 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. 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. This position is based in Cincinnati, OH.

Requirements

Bachelor's degree required, preferably in a Life Sciences field;
1-2 years of prior experience as a study coordinator or within the pharmaceutical industry, study start-up experience preferred;
Excellent organization and communication skills;
Knowledge of Microsoft® Office

Nice To Haves

CRC Experience

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; and
Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.