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Regulatory Submissions Coordinator

Regulatory Submissions Coordinator

Job Description

Are you an experienced CRA/ Site Manager/ IRB Associate looking for new opportunities in clinical research?

We are currently seeking key coordinators to join our Regulatory Submissions team in Clinical Operations.

The position is an office-based position in Cincinnati OH. The responsibilities include:

DESCRIPTION OF JOB DUTIES

  • Quality check on submission documents and site essential documents;
  • Interaction with US Central IRBs, sites and international associates;
  • Preparation and approval of informed consent forms; and
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges.

Job Requirements

QUALIFICATIONS/REQUIREMENTS

 

  • Experience as a Clinical Research Associate
  • Approximately 60-80% non-local, national travel is required;
  • Must have a minimum of a bachelor’s degree in a health or science related field;
  • Proficient knowledge of Microsoft® Office;
  • Outstanding communication skills; and
  • Must be detail-oriented and efficient in time management.

 

WHY MEDPACE?

 
Finding work that is challenging, where you are given the tools and training to succeed, where you are rewarded and are provided opportunities to grow professionally are just a few reasons talented individuals join the Medpace team. One Clinical Research Associate states:

  • “The thing I like most about Medpace is that this company is very nurturing. Everyone has each other’s back"
  • “…..Welcoming and fun environment"
  • “Training was a guided process. I never felt I was being thrown into a situation I didn’t feel comfortable with……….I had a mentor help me and a manager guide me"

 

ABOUT MEDPACE

 
Privately held and founded in 1992 with over 1,400 employees worldwide, Medpace is a global leader in research-based drug and device development. Medpace builds strong strategic partnerships with select Sponsors to advance the most efficient and cost-effective path to drug and device approval. Led by top therapeutic and regulatory experts with extensive experience in the advancement of pharmaceutical agents for use in multiple therapeutic specialties, Medpace has cultivated a culture of expertise. Global headquarters are in Cincinnati, Ohio.

 
WHAT TO EXPECT NEXT


 

We look forward to receiving your application which will be reviewed by a member of our recruitment team. If qualified, you will be contacted for an initial phone interview.

   

EO/AA Employer M/F/Disability/Vets

Job Snapshot

Employment Type Full-Time
Job Type Health Care, Research, Pharmaceutical
Education 4 Year Degree
Experience Not Specified
Manages Others No
Industry Pharmaceutical, Biotechnology, Healthcare - Health Services
Required Travel Road Warrior
Job ID US-RSC
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Regulatory Submissions Coordinator


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