Operations - Regulatory Specialist

Tribe Clinical Research•Greenville, SC

About The Position

The Regulatory Specialist works with investigators, study staff, Institutional Review Boards (IRBs), clinical trial sponsors, and federal regulatory agencies to ensure clinical trials meet regulatory requirements. The role supports regulatory compliance throughout the study lifecycle, from new study applications and study opening through ongoing maintenance and closeout. The specialist prepares, submits, tracks, and maintains regulatory documents; communicates with sponsors and IRBs; and uses electronic systems to file and manage study information. The position requires organization, multitasking, strong verbal and written communication, time management, and confidentiality. It may require travel, lifting up to 50 pounds, and sitting for extended periods. The role requires adherence to Tribe Clinical Research’s core values: growth orientation, humility and confidence, respectful communication, service and teamwork, openness to constructive feedback, and a positive attitude.

Requirements

Strong time management skills and ability to prioritize workflow.
Experience with electronic regulatory compliance systems.
Proficiency with Microsoft Office.
Strong verbal and written communication skills.
Ability to multitask and maintain confidentiality.
Ability to lift up to 50 pounds and sit for extended periods; the position may require travel.

Nice To Haves

Regulatory experience or experience in a clinical research practice setting.

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 and institutional and federal regulations.
Enter information into electronic systems as appropriate and upload documents into the electronic regulatory system.
Communicate with sponsors and IRBs.
Prepare and submit documents for new study applications and support studies from inception through accrual.
Prepare study closeout documentation, including final site delegation logs and other essential documents, and submit materials for IRB closure.
Prepare and present materials for monitoring visits, serve as the primary point of contact during visits, and independently follow up on and resolve regulatory issues identified during 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, uploaded to the server, and communicated to staff across all sites.
Ensure the PI reviews and acknowledges new protocol amendments and Investigator Brochures.
Complete and submit continuing review reports to the IRB as required.
Ensure licenses, GCPs, IATAs, and other applicable essential documents are current in paper or electronic 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.
Perform other duties as assigned.