Operations - Regulatory Specialist

Parkside Medical Group | The Onyx Group•Greenville, SC

About The Position

The Regulatory Specialist works with investigators, study staff, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies to ensure clinical trial regulatory requirements are met. The role prepares, submits, tracks, and maintains regulatory documentation; supports study openings, ongoing maintenance, monitoring visits, and closeouts; and communicates with sponsors, IRBs, principal investigators, and staff. The Specialist enters and files information in electronic systems and helps ensure studies comply with GCP, institutional, and federal requirements. The role requires strong organization, time management, workflow prioritization, multitasking, communication, and confidentiality. The position may require travel, lifting up to 50 pounds, and sitting for extended periods. The job holder must adhere to Tribe Clinical Research’s Core Values: being growth-oriented, humble but confident, respectful, service-minded and collaborative, receptive to constructive feedback, and positive when facing challenges. This description summarizes typical functions and is not exhaustive; other duties may be assigned.

Requirements

Strong time management and workflow prioritization skills.
Experience with electronic regulatory compliance systems.
Proficiency with Microsoft Office.
Strong verbal and written communication skills.
Excellent organization and multitasking abilities.
Ability to maintain confidentiality.
Ability to lift up to 50 pounds and sit for extended periods; travel may be required.

Nice To Haves

Regulatory experience or experience in a clinical research practice setting is preferred.

Responsibilities

Perform safety reporting required by study protocols, the FDA, and other regulatory bodies.
Prepare, track, and maintain correspondence and regulatory documentation required by the IRB, FDA, and other institutional and federal oversight committees.
Submit regulatory documents to the IRB and other governing bodies to maintain compliance with GCP, institutional, and federal regulations.
Enter information into electronic systems and upload documents into the electronic regulatory system.
Communicate with sponsors and IRBs.
Prepare and submit new study applications and open new studies from inception through accrual.
Prepare study closeout documentation, including final site delegation logs and other essential documents, and submit documentation for IRB closure.
Prepare and present materials for monitoring visits and serve as the primary point of contact during visits.
Follow up independently and resolve regulatory issues identified during monitoring visits.
Prepare and submit modifications, amendments, and continuing renewals for ongoing study maintenance.
Report non-compliance and unanticipated problems to the IRB as applicable.
Ensure new protocols are signed by the PI and uploaded to the server, and notify staff across all sites about new protocols.
Ensure new protocol amendments and Investigator Brochures are reviewed and acknowledged by the PI.
Complete and submit continuing review reports to the IRB as required.
Ensure licenses, GCPs, IATAs, and other applicable essential documents remain current in regulatory files.
Receive new informed consents and alert staff by email.
Receive and document monitor follow-up letters and review action items for completion after sponsor site visits.
Complete GCP, specialized regulatory, and sponsor training on protocol requirements.