Study Start-Up Coordinator- PharmD

About the Role

We are currently seeking full-time, office-based Regulatory Submissions Coordinators 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. We are seeking entry-level employees who want an exciting career where they can build a foundation in industry knowledge through our robust training program and develop their careers further.

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;
• 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 both experienced associates and those new to the industry. The SAM Training Program embraces evidence-based learning and 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;
• Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.

Requirements

• PharmD required;
• Some experience in an office setting is preferred;
• Excellent organizational and prioritization skills;
• Knowledge of Microsoft Office;
• Great attention to detail and excellent oral and written communication skills.

Travel: None

About Medpace

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 a 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, Medpace employs more than 6,000 people across 40+ countries.

Benefits

• 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, eco-friendly campus with an on-site fitness center;
• Structured career paths with opportunities for professional growth;
• Discounted tuition for UC online programs.

Awards and Recognition

• 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.