Project Coordinator (Site Activation and Maintenance)

Medpace, Inc.•Cincinnati, OH

3d•Onsite

About The Position

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Project Coordinators to join our Site Activation and Maintenance (SAM) 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 take the next step in your clinical research career, then this is the opportunity for you. 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

Bachelor's degree required (preferably in a Life Sciences field);
Some experience within the healthcare or clinical research field preferred;
Excellent organizational and prioritization skills;
Knowledge of Microsoft Office; and
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;
Gain exposure to multiple therapeutic areas including but not limited to Oncology/Hematology, Cardiovascular, and Metabolic;
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.