Clinical Regulatory Specialist

Location
Bethesda, MD
Posted
May 25, 2021
Ref
CR
Required Education
Masters Degree/MBA
Position Type
Full time

Piper Clinical Solutions is seeking a motivated Regulatory Affairs Specialist in Bethesda, MD to support an established research firm supporting both commercial and government clients with ongoing clinical research trials.

Responsibilities for the Regulatory Affairs Specialist:

  • Prepare scientific and regulatory documents such as study protocols, investigator brochures, informed consent forms, annual reports, IND applications, IDE applications, and summary reports
  • Regulatory correspondence with PI’s and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates
  • Prepare investigator/pharmaceutical company meeting minutes
  • Analyze preclinical/clinical research data, perform literature searches and extract information to support regulatory documents and prepare reports on findings
  • Maintain TMF related to ongoing studies and all regulatory documentation
  • Update, review, and maintain electronic databases for clinical trials

Requirements for the Regulatory Affairs Specialist: 

  • 3+ years of experience managing and submitting regulatory documentation for clinical trials (IRB/GCP/FDA)
  • Advanced knowledge of medical terminology
  • Working knowledge of database management programs, analytical tools, and CTMS
  • Ph.D. in science-related field preferred, Master’s Degree accepted

 

Compensation for the Regulatory Affairs Specialist:

  • Salary up to $100,000 based on experience
  • Benefits: Health, Dental, & Vision insurance and 401K