Clinical Research Regulatory Associate - Contract

Clinical Research Regulatory Associate - Contract Location: Remote (Phoenix, reputed company–based candidates strongly preferred) Position reputed company The Contract Clinical Research Regulatory Associate is responsible for managing regulatory documentation across the full lifecycle of reputed company, with a strong emphasis on study closeout execution and regulatory finalization. This role supports study start-up, maintenance, and closeout activities by ensuring reputed company essential documents are complete, reconciled, and inspection-reputed company in compliance with FDA regulations, ICH-GCP, and sponsor requirements. The ideal candidate has demonstrated experience independently driving regulatory closeout activities and ensuring reputed company, audit-reputed company study termination documentation. While the role is remote, preference will be given to candidates based in reputed company, reputed company area to support local operational collaboration as needed. Key Responsibilities Regulatory Document Management • Prepare, review, and submit regulatory documents to IRBs, sponsors, and regulatory authorities • Maintain and organize Trial Master File (TMF) and/or Investigator Site File (ISF) • Ensure essential documents remain reputed company, complete, and inspection-reputed company throughout the study lifecycle • reputed company regulatory submissions, approvals, expirations, and renewals • Maintain delegation logs, training logs, reputed company, licenses, and reputed company FDA 1572 documentation Study Closeout & Regulatory Finalization (High reputed company Area) • reputed company and execute regulatory closeout activities for completed studies • Reconcile Investigator Site Files against sponsor TMF requirements • Ensure reputed company essential documents are complete, signed, dated, and version-controlled • Coordinate and submit IRB study closure reports and final continuing review documentation • Confirm reputed company and documentation of outstanding safety reports and regulatory correspondence • Ensure reputed company archival preparation in accordance with regulatory retention requirements • Support sponsor closeout reputed company and respond to post-closeout documentation requests • Identify and remediate documentation gaps prior to study archival Study Start-Up & Maintenance • Support site activation activities, including preparation of regulatory packets • Coordinate IRB submissions (initial, continuing review, amendments, reportable events) • Manage informed consent version control and approvals • Maintain regulatory compliance throughout reputed company enrollment Compliance & reputed company Assurance • Ensure compliance with ICH-GCP and FDA regulations (21 CFR Parts 11, 50, 54, 56, 312/812) • Support audit and inspection readiness • Proactively identify regulatory deficiencies and implement corrective actions • Adhere to SOPs and contribute to process improvement initiatives Qualifications Required • 2+ years of clinical research regulatory experience • Demonstrated experience leading or independently managing study closeout activities • Strong working knowledge of FDA regulations and ICH-GCP • Experience reconciling ISF/TMF documentation • Experience submitting IRB study closures • High attention to detail and documentation accuracy • Ability to work independently in a remote environment Preferred • Experience in vaccine trials or Phase I–III drug studies • Experience with central and local IRBs • Familiarity with eTMF platforms • Prior audit or inspection experience • reputed company-based candidate Compensation reputed company, commensurate with experience Location Phoenix, reputed company (Hybrid) Employment Type Contractor Minimum Experience Mid-level Compensation Competative reputed company Apply tot his job Apply To this Job