Regulatory Research Coordinator

Job Locations United States-OH-Cincinnati
Category
Clinical Operations

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 approximately 3,500 people across almost 40 countries.

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 Clinical Operations 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 have openings ranging from entry to senior coordinator to best match your experience level. If you want an exciting career where you use 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, or 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; 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);
  • Some experience in an office setting is preferred for entry candidates; and
  • 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry is required for experienced candidates;
  • Excellent organizational and prioritization skills;
  • Knowledge of Microsoft Office; and
  • Great attention to detail and excellent oral and written communication skills.

 

Travel: None

Why Medpace?

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.

 

Awards:

  • Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
  • Recognized by Forbes as one of America's Best Mid-size Companies in 2021
  • 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.

 

EO/AA Employer M/F/Disability/Vets

2020-Top-Cincinnati-Workplace-Ribbon2021-Forbes-Banner

 

*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.

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