Clinical Trials Regulatory Lead – Start-up & Compliance

MUSC Health; South Carolina; On-site; USD 31,000 - 52,000; Full time

Job summary

MUSC Health seeks a Regulatory Coordinator for the Clinical Trial Research Program focusing on Pulmonary, Critical Care, Gastroenterology, Endocrinology Nephrology and Hepatology. You will work with Clinical Research Coordinators and the Program Manager to ensure regulatory deadlines are met and all SOPs are followed.

Responsibilities include study start-up, maintenance of regulatory files, IRB submissions, source documentation management, CIRB interactions, and providing administrative support

Qualifications

• Bachelor’s degree and one year of relevant program experience.
• Experience with regulatory documentation processes in clinical research.
• Familiarity with IRB policies, regulatory binders and source documentation.

Responsibilities

• Study start-up and maintenance: manage start-up packets, submissions and amendments.
• Regulatory documentation: maintain CVs, licensures, conflict-of-interest and other files.
• Source documentation: create and manage eSource databases and reports.
• Study monitoring: ensure complete and timely filings and action-item resolution.
• Administrative support and safety reporting: assist program leadership and handle reportable events.

Skills

Regulatory coordination

Clinical trials

Documentation management

IRB coordination

Education

Bachelor's degree

Job description

MUSC Health seeks a Regulatory Coordinator for the Clinical Trial Research Program focusing on Pulmonary, Critical Care, Gastroenterology, Endocrinology Nephrology and Hepatology. You will work with Clinical Research Coordinators and the Program Manager to ensure regulatory deadlines are met and all SOPs are followed.

Responsibilities include study start-up, maintenance of regulatory files, IRB submissions, source documentation management, CIRB interactions, and providing administrative support