Advarra

Regulatory Coordinator

Advarra

part-time

Posted on:

Location Type: Hybrid

Location: Richmond • Virginia • United States

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Tech Stack

Google Cloud Platform

About the role

  • Analyzes and implements applicable regulatory requirements, institutional policies, and guidance documents to ensure the protection, welfare, and safety of research participants.
  • Ensures adherence to Good Clinical Practice (GCP) standards across all phases of clinical research.
  • Coordinates the submission and review process for study protocols, amendments, continuing reviews, and reportable events by the Institutional Review Board (IRB), from study initiation through closure.

Requirements

  • Bachelor’s degree with 3+ years of relevant experience OR associate’s degree with 4+ years of experience.
  • Demonstrated experience with an electronic regulatory filing system
  • Current training in human subjects protection education, Good Clinical Practice, and HIPAA Privacy
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory requirements analysisGood Clinical Practice (GCP)protocol submissionamendments reviewcontinuing reviewsreportable events managementhuman subjects protectionHIPAA Privacy