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Clinical Research Regulatory Specialist

1 month ago

Richmond, Virginia, United States Clinical Research Partners, LLC Full time
Job Description

We are seeking a highly motivated and detail-oriented Clinical Research Regulatory Specialist to join our team at Clinical Research Partners, LLC. The ideal candidate will have a strong understanding of the clinical research and pharmaceutical industry, as well as excellent communication and organizational skills.

Key Responsibilities:
  • Ensure compliance with regulatory requirements and industry standards for clinical research studies.
  • Coordinate and maintain accurate records of study start-up, including completion and submission of essential documentation.
  • Review and submit protocol-specific informed consent forms and investigator brochures.
  • Compile and maintain the Investigator Site File (ISF) binder for all protocols at the study site.
  • Assist with the development of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
  • Perform other regulatory functions within the Compliance section of the Regulatory department.

The successful candidate will have a valid driver's license and be willing to visit our clinician offices throughout the week to drop off documents, obtain and collect documents, etc. Mileage/vehicle reimbursement will be provided for such services.

Requirements:
  • Strong understanding of the clinical research and pharmaceutical industry.
  • Excellent communication and organizational skills.
  • Ability to work independently and as part of a team.
  • Valid driver's license.