Study Start-Up Coordinator - Clinical Research Coordinator Experience

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

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.

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.

Qualifications:

* 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 organization and communication skills; and
* Knowledge of Microsoft(r) Office
*  
* Travel: None

Supervisor Responsibilities: None
			

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