UNIV - Regulatory and Grant Administration Coordinator - Department of Dermatology

Medical University of South Carolina • Charleston, SC

3d • $45,300 - $77,000 • Onsite

About The Position

The Regulatory and Grant Administration Coordinator is responsible for coordinating regulatory, study start-up, maintenance, and grant administration activities for clinical research studies. This role ensures compliance with institutional, sponsor, federal, and regulatory requirements while supporting investigators and research teams throughout the study lifecycle.

Requirements

• A bachelor's degree and three years of relevant program experience.

Responsibilities

• Conduct and coordinate study feasibility assessments.
• Facilitate Site Qualification Visits (SQVs) and support sponsor interactions.
• Utilize SPARC to coordinate research-related services and resources required for clinical trials, including study set-up, ancillary service requests, departmental approvals, study calendars, budgeting support, and activation activities to ensure operational readiness and institutional compliance.
• Coordinate with ancillary hospital services and support departments to ensure all required study-related processes, approvals, and operational workflows are established during study start-up and prior to activation.
• Submit and maintain Protocol Reimbursement Analysis (PRA) requests and amendments.
• Complete EPIC research build requests and order set development in collaboration with clinical and operational teams.
• Prepare and submit initial Institutional Review Board (IRB) applications.
• Complete and track pre-activation regulatory and study start-up documentation.
• Manage electronic regulatory (eReg) systems, including pushing studies into eReg platforms, adding and maintaining study personnel access and documentation.
• Prepare and submit continuing reviews, reportable events, amendments, and other regulatory updates as required.
• Maintain accurate regulatory files and ensure ongoing compliance with institutional, sponsor, GCP, and federal requirements.
• Assist with grant proposal preparation and submission activities.
• Develop, prepare, and coordinate grant budgets and budget justifications in collaboration with investigators and departmental leadership, ensuring compliance with sponsor and institutional requirements.
• Prepare and submit grant applications, modifications, and related documentation through Cayuse.
• Coordinate administrative components of sponsored research submissions.
• Track grant deadlines, approvals, and compliance requirements to ensure timely submission and adherence to sponsor and institutional policies.
• Collaborate with investigators, department administrators, and institutional offices to facilitate timely grant submissions and post-award documentation.
• Assist with budget revisions, re-budgeting requests, no-cost extensions, and other pre-award administrative activities as needed.
• Support post-award documentation, reporting, and administrative processes related to sponsored projects.
• Register and maintain applicable studies in ClinicalTrials.gov, including initial registration, record updates, and results reporting as required.
• Prepare and maintain supporting documentation required for grant applications, progress reports, regulatory compliance, and sponsor submissions.
• Coordinate collection and submission of investigator biosketches, other support documents, current and pending support information, and related proposal materials.
• Complete other grant administration and research support activities as assigned.
• Serve as a liaison between investigators, sponsors, institutional offices, and regulatory bodies.
• Monitor study timelines to ensure timely completion of regulatory and administrative milestones.
• Support audit and inspection readiness activities.
• Maintain study records and documentation in accordance with institutional policies and regulatory requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level