Study Start-Up Coordinator- PhD

Medpace, Inc.•Cincinnati, OH

4d•Onsite

About The Position

Our clinical operations activities are growing rapidly, and we are currently seeking 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 are seeking entry level employees. If you want an exciting career where you can build a foundation in industry knowledge through our robust training program and develop and grow your career even further, then this is the opportunity for you. SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAM Medpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence- based learning & development models to advance professional learning and employee performance. In the program, you will… • Complete independent learning modules, interactive exercises, and team workshops through the core curriculum; • Gain exposure to real-world tasks through a robust mentoring program; and • Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.

Requirements

A minimum of a PhD is required (preferably in a Life Sciences field)
3.5 GPA and above preferred
Some experience in an office setting is preferred
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
Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges