UNIV-Research Program Coordinator, College of Nursing
About The Position
The MUSC College of Nursing is seeking a full-time Program Coordinator to provide day-to-day operational coordination for the NIH-funded UNDERSTAND study, a remotely delivered behavioral clinical trial focused on reducing stress among caregivers of people living with mild cognitive impairment or early-stage Alzheimer’s disease and related dementias. Under the direction of the Principal Investigator (PI), the coordinator serves as the study’s primary operational coordinator. The role coordinates participant recruitment, screening, consent, enrollment and retention; regulatory and study documentation; REDCap and data-quality activities; participant safety and protocol-deviation tracking; participant compensation; and study reporting. The coordinator works collaboratively with investigators, intervention personnel, the Independent Safety Officer, collaborating research centers, community partners, and MUSC research and regulatory offices. The position also supports study meetings, NIH progress reporting, ClinicalTrials.gov activities, study-specific procedures and training, and study closeout.
Requirements
- A bachelor's degree.
- Three years of relevant program experience.
Nice To Haves
- Experience coordinating NIH-funded clinical, behavioral, or community-based research.
- Experience with longitudinal or remotely delivered intervention studies.
- Experience working with caregivers, older adults, or dementia-related research.
- Experience with REDCap, including e-consent, survey workflows, data-quality review, and reporting.
- Experience with regulatory submissions, sIRB/reliance activities, adverse-event tracking, and protocol deviations.
- Experience developing study SOPs, workflows, checklists, and training materials.
- Strong organizational, communication, problem-solving, and independent project-management skills.
Responsibilities
- Coordinate IRB-approved recruitment with clinical, community, and research partners; respond to prospective participants and conduct protocol-approved prescreening and eligibility procedures, including FAST and PAR-Q+ procedures.
- Conduct informed-consent activities when appropriately trained and delegated, maintain participant screening, recruitment, enrollment, withdrawal, and retention records, and monitor recruitment metrics and barriers.
- Serve as the primary operational contact for participants and coordinate baseline, intervention, post-intervention, and six-month follow-up activities.
- Provide protocol-approved instructions, schedules, materials, intervention access, reminders, and retention support; track missed assessments, withdrawals, technology concerns, and participant-reported barriers.
- Coordinate facilitated intervention sessions and qualitative interviews with designated study personnel and support fidelity monitoring.
- Maintain current regulatory and study documentation; track deadlines; prepare regulatory materials, amendments, personnel changes, and reportable-event documentation for PI review.
- Coordinate sIRB/reliance documentation and communications with collaborating research centers, as applicable.
- Coordinate study meetings, agendas, action items, and operational follow-up; support NIH progress reporting, ClinicalTrials.gov activities, and other required reports.
- Coordinate development, testing, and maintenance of study-specific REDCap instruments and workflows, electronic case report forms, and participant tracking systems.
- Conduct routine data-quality reviews, identify missing, incomplete, or discrepant data, facilitate query resolution, and maintain study reports.
- Support authorized datasets, data documentation, deidentification, archival, and data-sharing activities.
- Document adverse events, participant concerns, protocol deviations, and potential safety issues; escalate safety concerns and potentially reportable events to the PI and designated safety personnel.
- Maintain safety, deviation, and corrective-action tracking records; coordinate internal quality-assurance reviews and prepare materials for Independent Safety Officer review.
- Track monitoring findings and corrective actions through resolution and maintain audit-ready records.
- Coordinate, document, and reconcile participant compensation according to approved study procedures.
- Coordinate study materials, equipment, supplies, vendors, and other approved operational resources; communicate discrepancies or resource needs to the PI or appropriate administrative personnel.
- Develop and maintain study-specific SOPs, workflows, checklists, scripts, and training materials; coordinate protocol-specific training and maintain training and delegation documentation.
- Support study closeout, final data reconciliation, regulatory-file review, archival, and data-sharing requirements.
- Perform other study-related duties consistent with the assigned classification and approved protocol.
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What This Job Offers
Job Type
Full-time
