Clinical Research Regulatory Specialist Job Description

As a Physicians Research Group (“PRG”) employee, you have a unique opportunity to change lives on our research campus, in our state and around the country. PRG employees offer their boundless energy, creative problem-solving skills, and dedication to build stronger minds and a healthier world.

PRG has an outstanding opportunity for a full-time Clinical Research Regulatory Specialist. The Regulatory Specialist is responsible for all regulatory documents from start-up through close-out. He/she is responsible for completing regulatory start-up, conducting ongoing quality assurance, and adhering to PRG’s SOPs in order to maintain audit-readiness. We are open to new college graduates with a 3.5 or higher GPA.

RESPONSIBILITIES:

• Manages credentialing for staff and investigators (maintenance and updates for CVs, ML, DEA license, MICA, GCP training)
• Perform regulatory activities including regulatory binder maintenance and IRB submissions, as required
• Complete all start-up submission documentation and print/file documents in regulatory binders and/or electronically in e-regulatory system
• Establish expiry date of approval and ensure this information is accurately entered into CTMS and calendared for follow-up
• Complete all continuing review documentation and submit to IRB/sponsor/CRO accordingly
• Complete all close-out documentation and submit to IRB/sponsor/CRO accordingly
• Archive files and maintain tracking information
• Follow ICF amendment and protocol amendment processes
• Follow safety report management and alert processes
• Schedule, attend, and support in the facilitation of SIV/IMV/COV

REQUIREMENTS:

• The ideal candidate should possess the following skills:
  • Sincere attention to detail and excellent organizational skills
  • Personable and professional demeanor
  • Strong written, verbal, and interpersonal skills
  • Strong computer skills including CTMS, project management platforms, and e-regulatory

PREFERRED QUALIFICATIONS: 

• Bachelor’s degree
• Previous experience in clinical research