Biology, Biotech and Pharmaceutical, Cardiology, Cardiovascular, Clinical Research, Clinical Trial, Clinical Trial Management, Communication Skills, Contract Research Organization (CRO), Detail Oriented, Disease, Drug Development, Endocrinology, Establish Priorities, Fitness, Healthcare, Hematology, Hospital, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Leadership, Maintain Compliance, Medical Equipment, Medical Office, Mentoring, Metabolic Disorders, Microsoft Office, Nonprofit, Oncology, Organizational Skills, Presentation/Verbal Skills, Project/Program Coordination, Regulations, Regulatory Compliance, Regulatory Requirements, Sports, Startup, System Start-Up, Training Program, Writing Skills
Job Summary
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Project Coordinators to join our Site Activation and Maintenance (SAM) 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. If you want to build on your foundational knowledge and take the next step in your clinical research career, 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 (including submissions to Institutional Review Boards (IRB);
- Maintain timelines for study start-up through both internal and external collaboration;
- Gain exposure to multiple therapeutic areas including but not limited to Oncology/Hematology, Cardiovascular, and Metabolic;
- 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
- Bachelor''s degree required (preferably in a Life Sciences field);
- Some experience within the healthcare or clinical research field preferred;
- Excellent organizational and prioritization skills;
- Knowledge of Microsoft Office; and
- Great attention to detail and excellent oral and written communication skills.
Travel: None
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 6,000 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.
Cincinnati 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
- Discounts on local sports games, fitness gyms and attractions
- Modern, ecofriendly campus with an on-site fitness center
- Structured career paths with opportunities for professional growth
- Discounted tuition for UC online programs
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.