UNIV - Regulatory and Grant Administration Coordinator - Department of Dermatology

Job Description Summary

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.

Medical University of South Carolina (MUSC - Univ)

Employee

Research Grant

CC000961 COM Dermatology CC

Hourly

University-GEN
08

45,300.

- 77,000.000

40

• 30% - Start Up Coordination
  • 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.
• 30% - Regulatory Coordination
  • 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.
• 25% - Grant Administration
  • 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 Clinical Trials.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.
• 15% - Study Coordination and Compliance Support
  • 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.

Minimum Requirements:

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

Physical Requirements:

(

Note:

The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while…