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Regulatory Submissions (Study Start Up) Coordinator - Denver
- Clinical Operations
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 approximately 3,500 people across almost 40 countries.
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you can use your previous expertise and can develop and grow your career even further, then this is the opportunity for you!
- Communicate with research sites regarding the distribution and review of site essential documentation;
- Maintain and perform quality review of Trial Master File (TMF);
- Collect, review, organize, and assemble regulatory start-up submissions;
- Maintain timelines for site start-up;
- 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 submissions issues and challenges
- A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
- 1 year of work experience, experience in clinical research is preferred;
- Excellent organizational and prioritization skills;
- Knowledge of Microsoft Office; and
- Great attention to detail and excellent oral and written communication skills.
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
- Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
- Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
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*WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.