Job Description
Job Summary
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.
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 (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 other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.
Qualifications
- 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.
Medpace 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.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Denver Perks - Flexible work environment
- Competitive PTO packages, starting at 20+ days
- Competitive compensation and benefits package
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Community involvement with local nonprofit organizations
- Structured career paths with opportunities for professional growth
- Discounts on local sports games, fitness gyms and attractions
- Modern, ecofriendly campus with an on-site fitness center
- RTD Eco Pass
- Secure bike storage room
Awards - Named a Top Workplace in 2024 by The Cincinnati Enquirer
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Job Tags
Permanent employment, Full time, Contract work, Temporary work, Work at office, Local area, Immediate start, Flexible hours,