Clinical Research Regulatory Associate - Contract

Clinical Research Regulatory Associate - Contract
Location: Remote (Phoenix, Arizona–based candidates strongly preferred)

Position Overview

The Contract Clinical Research Regulatory Associate is responsible for managing regulatory documentation across the full lifecycle of clinical trials, with a strong emphasis on study closeout execution and regulatory finalization.

This role supports study start-up, maintenance, and closeout activities by ensuring all essential documents are complete, reconciled, and inspection-ready in compliance with FDA regulations, ICH-GCP, and sponsor requirements. The ideal candidate has demonstrated experience independently driving regulatory closeout activities and ensuring timely, audit-ready study termination documentation.

While the role is remote, preference will be given to candidates based in the Phoenix, Arizona 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 current, complete, and inspection-ready throughout the study lifecycle
• Track regulatory submissions, approvals, expirations, and renewals
• Maintain delegation logs, training logs, CVs, licenses, and Form FDA 1572 documentation

Study Closeout & Regulatory Finalization (High Priority Area)
• Lead and execute regulatory closeout activities for completed studies
• Reconcile Investigator Site Files against sponsor TMF requirements
• Ensure all essential documents are complete, signed, dated, and version-controlled
• Coordinate and submit IRB study closure reports and final continuing review documentation
• Confirm resolution and documentation of outstanding safety reports and regulatory correspondence
• Ensure proper archival preparation in accordance with regulatory retention requirements
• Support sponsor closeout visits 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 active enrollment

Compliance & Quality 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
• Arizona-based candidate

Compensation
Hourly, commensurate with experience

Location

Phoenix, Arizona (Hybrid)

Employment Type

Contractor

Minimum Experience

Mid-level

Compensation

Competative Hourly