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Regulatory Affairs Specialist

Job Attributes

Job Id:

22186

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20810

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is in search of a driven Regulatory Affairs Specialist in Bethesda, MD to support an established research firm as they provide clinical trial support to commercial and federal clients. 

Responsibilities for the Regulatory Affairs Specialist:

  • Requires the preparation of regulatory and scientific documents including but not limited to protocols, investigators brochures, informed consent forms (ICF), investigational new drugs (IND), investigational device exemption (ICE) applications, and institutional review board (IRB)
  • Maintain trial master file and associated ICF’s, central regulatory files (CRF’s), and other regulatory forms.
  • Input, update, and organize databases used for particular trials
  • Work in team setting to provide support to specified clinical trials
  • Analyze preclinical and clinical data to prepare reports
  • Perform literature research citing information to support regulatory documentation

 

Requirements for the Regulatory Affairs Specialist:

  • 3+ years of clinical research experience (1+ years experience acceptable with Ph. D)
  • High level knowledge of regulatory documentation and terminology (GCP, IRB, FDA, etc.)
  • Working knowledge of database and spreadsheet management
  • Ph.D. in science related field preferred, MS acceptable

Compensation for the Regulatory Affairs Specialist:

  • Salary up to $75,000 based on qualification of skills
  • Benefits include Health/Dental/Vision coverage, 401K

 

Please send all qualified resumes to: dmanley@pipercompanies.com

 

Keywords:

International Review Board, IRB, regulatory, scientific, protocols, investigators brochure, ICF, intermediate care facilities, IND, investigational new drugs, IDE, investigational device exemption, applications, TMF, trial master file, clinical trial, clinical, Good Clinical Practice, GCP

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Job Id:

22186

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20810

Security Clearance:

No Clearance

Business Unit:

Piper Companies