Regulatory Specialist

Be Well Clinical Studies•Lincoln, NE

1d•Remote

About The Position

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.

Requirements

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

Nice To Haves

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)

Responsibilities

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
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
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
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