Experienced Study Start-Up Research Coordinator
About The Position
Medpace is seeking an experienced Study Start-Up Coordinator to join its Regulatory Submissions team in Denver, Colorado. This office-based role supports clinical trial management and study start-up, working independently and collaboratively with colleagues and research sites. The coordinator gathers and manages regulatory documentation, supports site activation, and helps ensure compliance with applicable requirements. The position includes participation in Medpace’s Site Activation & Maintenance (SAM) Training Program, which provides learning modules, interactive exercises, team workshops, mentoring, and practical exposure to study start-up work.
Requirements
- Bachelor’s degree.
- At least 3 years of experience as a Clinical Research Coordinator or in an industry-equivalent role.
- Experience with Institutional Review Board (IRB) submissions and Informed Consent Form development.
- Knowledge of Microsoft Office.
- Excellent organizational and prioritization skills.
- Strong attention to detail and excellent oral and written communication skills.
Nice To Haves
- A degree in a Life Sciences field is preferred.
Responsibilities
- Communicate with research sites, including doctors’ offices, universities, and hospitals, to collect essential documents required before sites begin screening clinical trial participants.
- Maintain trial documents in the Trial Master File (TMF) and conduct ongoing quality reviews.
- Collect, review, organize, and assemble regulatory start-up submissions, including submissions to Institutional Review Boards.
- Maintain study start-up timelines through internal and external collaboration.
- Provide advice and guidance to internal and external team members to support compliance with applicable regulations and requirements.
- Review relevant regulations and guidance and develop proactive solutions to regulatory issues and challenges.
Benefits
- Medical, dental, and vision benefits.
- 401(k).
- Vacation policy, sick days, and paid holidays.
- Work-from-home flexibility, including occasional work from home for eligible positions after training.
- Short-term and long-term disability insurance.
- Health savings and flexible spending accounts.
- Life and AD&D insurance.
- Pet insurance.
- Reimbursement for travel expenses, including food and gas allowance, rental cars, and hotel accommodations.
- Competitive compensation programs that recognize and reward performance.
- Company-sponsored social events.
- Training and continuous learning opportunities.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
