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Regulatory Affairs Specialist

Job Attributes

Job Id:

32144

Job Category:

Biotechnology

Job Location:

Durham, NC  27704

Security Clearance:

No Clearance

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Regulatory Affairs Specialist

Piper Companies is seeking an experienced Regulatory Affairs Specialist in the Raleigh-Durham, North Carolina (NC) area. This Regulatory Affairs Associate will play a pivotal role in overseeing multiple clinical trials in accordance with Federal and Industry regulations.

 

Responsibilities of the Regulatory Affairs Specialist Include:

  • Responsible for overseeing and facilitating the IRB approval process for trial protocols, Informed Consent Forms (ICFs), and any amendments
  • Ensure that all regulatory documentation is accurate and provide them to the IRB for review
  • Maintain communication with the IRB by providing updates on any protocol deviations
  • Support research teams through start-up, maintenance, and close-out phases by ensuring all required documentation is present, accurate, and up to date
  • Provide training for research teams regarding any protocol changes

 

Qualifications of the Regulatory Specialist Include:

  • 2-6 years of experience in Regulatory Affairs in Clinical Research
  • Must have hands-on experience authoring and submitting IRB applications and updates
  • Past experience authoring and reviewing ICFs
  • Bachelor’s degree in Public Health, Clinical Research, or related field required

 

Compensation of the Regulatory Affairs Specialist Includes:

  • Salary Range: $50,000-$75,000 dependent on experience level
  • Benefits: Medical, Dental, Vision, 401k

 

Key Words:

Regulatory Affairs, informed consent, ICF, IRB, submissions, protocol, deviations, author, amendments, site, review board, benefits, medical, dental, vision, 401k, Durham, North Carolina, NC

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New Search

Job Id:

32144

Job Category:

Biotechnology

Job Location:

Durham, NC  27704

Security Clearance:

No Clearance

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions