UNIV - Regulatory Coordinator - Department of Medicine: Division of Pulmonary

Medical University of South Carolina•Charleston, SC

3d•$45,300 - $77,000•Onsite

About The Position

This position will serve as the Regulatory Coordinator for the Clinical Trial Research Program specializing in Pulmonary, Critical Care, Gastroenterology, Endocrinology Nephrology and Hepatology. This position will work with the Program’s Clinical Research Coordinators and Clinical Research Program Manager to ensure all deadlines are met. Responsibilities include coordinating and performing study specific regulatory processes for the Program while ensuring that appropriate regulations and Standard Operating Procedures (SOPs) are followed.

Requirements

A bachelor's degree and one year of relevant program experience.

Responsibilities

Receive start-up packet from sponsor; initiate and monitor study start-up activities, including all necessary documents.
Upon activation, submit amendments and any changes to the study to the IRB and notify study team of all approvals.
Submit continuing reviews.
Answer questions and provide documents as requested by the Investigator, Program Manager, and study sponsor.
Maintains accurate study registration as applicable (ClinicalTrials.gov, etc) for all investigator-initiated projects; provides guidance on issues such as when to re-consent subjects, when to report events per IRB policy.
Maintain all necessary regulatory documents, such as CVs, medical licensure, note-to-files, conflict of interest, laboratory certifications, and any other documents required for the Program’s regulatory files.
Responsible for building electronic regulatory binders and maintaining the electronic files.
Oversee regulatory documentation for multi-site projects, with MUSC acting as the lead site; responsible for creating the templates that will be utilized.
Create and maintain eSource documentation database for use by research coordinators.
Responsible for maintaining database for the life of the study from creation to closure. This includes coding and building of source structure, field editing based on protocol amendments or usage needs, creating reports and alerts as needed, and alerting study team of any changes made.
Ensure all documents are complete and filed (either physically or electronically) in the regulatory binder.
Works with the study monitor to ensure that all action items are resolved in a timely manner.
Reviews corrective action plans with the Regulatory Manager to ensure any items are addressed.
Responsible for being familiar and working with any CIRBs used by the Program.
Will be expected to stay current on their processes and application changes that the CIRB may have; maintains CIRB polices at the site level for reference.
Will provide administrative support as needed to the Program Manager, Accountant Fiscal Manager, Education & Operations Specialist, Accountant/Fiscal Analyst, and Regulatory Manager.
Examples include, scheduling meetings, providing assistance to any Program events, completing site tours, and other tasks as needed.
Completes IRB and/or sponsor reportable events independently.
Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.
Assist with other study tasks or projects as needed.