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Jobs · Analyst · Ohio

Experienced Study Start-Up Coordinator

Medpace · Cincinnati, OH · 1 mo ago
On-siteAnalystFull-time

About the Role

We are seeking a full-time, office-based Regulatory Submissions Coordinator to join our Study Start-up team. This position works both independently and collaboratively to meet common goals and plays a key role in the clinical trial management and study start-up process. If you want to build on your foundational knowledge and previous experience to develop and grow your career, 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;
  • Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
  • 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 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

  • Bachelor's degree required (preferably in a Life Sciences field);
  • 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry specializing in study start-up is required;
  • 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) providing 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 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

  • 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.

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