Regulatory Specialist

Position Summary

Be Well Clinical Studies is seeking a detail-oriented and compliance-driven Regulatory Specialist to support clinical research operations across all study protocols and sites. This role is responsible for maintaining regulatory integrity, ensuring audit readiness, and supporting sponsor and FDA compliance in accordance with ICH-GCP guidelines.

The Regulatory Specialist plays a critical role in protecting subject safety, study credibility, and organizational reputation by ensuring documentation accuracy, timely submissions, and adherence to protocol and regulatory standards.

This position works closely with Principal Investigators, Clinical Research Coordinators, Sponsors, Monitors, and the Clinical Operations Manager to maintain regulatory excellence across all active studies.

Key Responsibilities

Regulatory Oversight & Documentation

• Maintain complete and audit-ready Investigator Site Files (ISF) for all active protocols
• Prepare, submit, and track IRB submissions, amendments, continuing reviews, and reportable events
• Ensure timely collection and filing of regulatory documents (1572s, CVs, licenses, training records, delegation logs, IRB correspondence, study files)
• Maintain essential document trackers and regulatory binders (electronic and physical)
• Oversee version control of protocols, ICFs, and study materials
• Maintain and routinely update study delegation of authority logs and alignment with staff roles and training records
• Maintain, track, and routinely update BWCS staff CVs, ensuring currency

Compliance & Audit Readiness

• Ensure adherence to ICH-GCP, FDA regulations, and sponsor requirements
• Prepare for monitoring visits, sponsor audits, and regulatory inspections
• Address findings with corrective and preventative action (CAPA) support
• Track regulatory timelines and ensure no lapse in approvals

Cross-Functional Coordination

• Partner with CRCs to ensure regulatory alignment before subject enrollment
• Support Principal Investigators in maintaining licensure and training compliance
• Communicate proactively with sponsors and IRBs regarding documentation needs
• Support study start-up and close-out regulatory processes

Quality & Process Improvement

• Conduct periodic reviews of CVs, training records, and delegation logs to identify discrepancies and support inspection readiness
• Identify documentation gaps and implement corrective systems
• Assist in development and maintenance of SOPs
• Support internal quality control audits
• Ensure proper documentation of protocol deviations and reportable events

Required Qualifications

• Bachelor’s degree preferred (science or healthcare-related field ideal)
• 1–3 years of clinical research regulatory experience
• Strong understanding of ICH-GCP guidelines
• Experience with IRB submissions and essential regulatory documentation
• Experience with CTMS / eRegulatory systems (CRIO preferred)
• Strong organizational skills and attention to detail
• Ability to manage multiple protocols and deadlines simultaneously

Preferred Qualifications

• Experience supporting multi-site research operations
• Audit or inspection experience
• Knowledge of FDA 21 CFR Part 11
• Familiarity with sponsor portals and regulatory tracking systems
• CCRC or CCRP certification (preferred but not required)

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  Work Environment

• Remote role
• High-detail, documentation-intensive environment
• Multi-site regulatory coordination