Clinical Research Regulatory Associate - Contract
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
- 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
- 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
- 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
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What This Job Offers
Career Level
Mid Level
Education Level
No Education Listed
