Medpace, Inc.
Location
Irving, Texas
The Study Start-Up Coordinator will communicate with research sites to collect essential documents for clinical trials and maintain quality reviews of trial documents. They will also provide guidance to ensure compliance with regulations and develop solutions to regulatory challenges.
Candidates must have a bachelor's degree, preferably in a Life Sciences field, and 1-5+ years of experience in clinical research or study coordination. Excellent organization and communication skills, along with knowledge of Microsoft Office, are also required.
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator 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. *This position is based in Dallas, TX.
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.
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® Office Travel: None Supervisor Responsibilities: None
Why Medpace?
