Job Description

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.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC000961 COM Dermatology CC

Pay Rate Type

Hourly

Pay Grade

University-GEN08

Pay Range

45,300.00 - 61,100.00 - 77,000.000

Scheduled Weekly Hours

40

Work Shift

Job Duties:

• 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 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.
• 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.

Additional Job Description

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 walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent)

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees