Operations - Regulatory Specialist

Title: Regulatory Specialist

Position: Full-Time, Hourly

Based at: TCR – Greenville 

Position Summary: The Regulatory Specialist works with investigators, study staff, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies to ensure that regulatory requirements for clinical trials are met.

Key Skills and Competencies:

• Regulatory experience preferred or experience in a clinical research practice setting.
• Possess time management skills and workflow prioritization.
• Experience with electronic regulatory compliance systems.
• Proficient with Microsoft Office.
• Strong verbal and written communication skills.

Primary Accountabilities:

• Perform safety reporting requirements of the study protocols, FDA, and other regulatory bodies.
• Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA, and other institutional and federal oversight committees.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
• Enter information into electronic systems as appropriate.
• Sponsor and IRB communication.

General Accountabilities:

• Prepare and submit all required regulatory documents for:

• New study applications; successfully open new studies from inception to accrual.
• Study closeout to include final site delegation logs and other essential documents and submit for IRB closure.

• Prepare and present materials for monitoring visits; serve as primary point of contact during visits.
• Independently follow up and resolve all issues related to regulatory concerns identified during monitoring visits.
• Prepare and submit modifications/amendments and continuing renewals for ongoing study maintenance.
• Help prepare and file all study closeout documentation.

• Report non-compliance and unanticipated problems to the IRB as applicable. 

• Ensure new protocols are signed by the PI and uploaded to the server.
• Notify staff of all new protocols across all sites.

• Ensure new protocol amendments and Investigator Brochures are reviewed and acknowledged by the PI.

• Complete and submit all continuing review reports to the IRB for studies as required.
• Upload documents into the electronic regulatory system for filing.
• Ensure that all licenses, GCP’s, IATA’s, and other applicable essential documents are current in regulatory files (whether paper or electronic).
• Receive new Informed Consents and alert the staff via email.
• Receive and document monitor follow-up letters and review for completion of action items after sponsors visit the site to review study documents.

• Complete GCP training and additional specialized regulatory training and sponsor training on protocol requirements.

This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties.  Responsibilities, tasks, and duties of the job holder might differ from those outlined in the job description, and other duties, as assigned, might be part of the job.

A person in this position must be highly organized, utilize excellent verbal and written communication, and be able to multitask.  This position requires excellent time management, communication skills, and confidentiality. This position may require travel, lifting (up to 50 pounds), and sitting for extended periods.

This position requires adherence to Tribe Clinical Research’s Core Values as outlined:

• We are passionate about working for a GROWTH ORIENTED company.
• We exhibit a HUMBLE but CONFIDENT approach to work.
• We communicate what needs to be said RESPECTFULLY.
• We love serving others and WORKING TOGETHER for the greater good.
• We can take constructive feedback well and have a POSITIVE ATTITUDE even when the going gets tough.

Reporting Structure: Regulatory Manager