Experienced Study Start-Up Research Coordinator - Denver

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 currently have openings at the experienced coordinator level. If you want an exciting career where you build upon the foundation of your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

• 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 (includes submissions to Institutional Review Boards);
• 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 otherprofessionals revolutionizing efficient and seamless study start-up to advance clinical trials.

• A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
• Experience as a Clinical Research Coordinator or industry equivalent (minimum 3 years);
• Excellent organizational and prioritization skills;
• Experience with Institutional Review Board (IRB) submissions and Informed Consent Form development is required;
• Knowledge of Microsoft Office; and
• Great attention to detail and excellent oral and written communication skills.

Compensation

A target salary range of $40,000 - $100,000. Your compensation will be based on your skills and experience. Medpace offers the following benefits for eligible positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, and pet insurance. For more details, please discuss with your recruiter.