Job Description Summary
The Freitas-Lemos Lab within the Department of Psychiatry and Behavioral Sciences is seeking a highly organized and experienced Clinical Research Program Manager to support operations across a growing portfolio of clinical research studies, including pilot studies and multisite research collaborations.
As a newly established lab at MUSC, the Program Manager will work closely with the Principal Investigator to develop and implement the operational infrastructure needed to support the lab’s research activities while coordinating multiple studies at different stages of development and implementation. Responsibilities will include study startup and implementation, development of research workflows and standard operating procedures, staff coordination, regulatory activities, data and biospecimen workflows, coordination with collaborating institutions, and budget and administrative tracking.
The ideal candidate is an experienced clinical research professional with strong organizational, regulatory, and leadership skills who is comfortable establishing research processes, coordinating multiple concurrent studies and collaborations, and helping build efficient systems to support a growing research program.
Entity
Medical University of South Carolina (MUSC - Univ)
Worker Type
Employee
Worker Sub-Type
Research Grant
Cost Center
CC001039 COM PSYCH Addiction Science CC
Pay Rate Type
Hourly
Pay Grade
University-GEN06
Pay Range
37,944.00 - 49,266.00 - 60,690.000
Scheduled Weekly Hours
40
Work Shift
Job Description
FLSA: Hourly
Work Schedule: Monday - Friday, 8:30 am - 5:00 pm
Job Duties:
30% – Clinical Research Operations and Study Coordination: Provide operational coordination across the lab’s portfolio of pilot studies, clinical research studies, and multisite research collaborations. Coordinate study startup, implementation, maintenance, and closeout activities; develop and maintain study workflows, standard operating procedures (SOPs), training materials, and documentation systems; coordinate recruitment, screening, study visits, and participant tracking; oversee study supplies, equipment, investigational products when applicable, and biospecimen collection, processing, storage, and shipping workflows; facilitate communication and operational coordination with collaborating investigators and research sites; identify operational bottlenecks and implement process improvements; and monitor study progress, recruitment, staffing needs, and visit forecasting across studies.
20% – Staff Coordination and Operational Leadership: Coordinate day-to-day research activities and facilitate communication among research staff, trainees, investigators, and collaborators involved in the lab’s studies. Support onboarding and training of research personnel; coordinate team meetings and follow-up activities; assist with assigning and tracking study-related tasks; and help identify opportunities to improve research workflows and processes. Support recruitment and onboarding of new staff, including coordination of position postings, interviews, required documentation, and institutional processes. Over time, the position may assume formal supervisory responsibilities for other research staff.
15% – Regulatory and Compliance Coordination: Coordinate preparation and submission of study protocols, consent forms, amendments, continuing reviews, and other regulatory applications. Maintain accurate and comprehensive regulatory and training documentation in accordance with applicable Institutional Review Board (IRB) requirements, sponsor expectations, Good Clinical Practice (GCP) guidelines, and federal, state, and institutional requirements. Coordinate eIRB/IRB communications and regulatory timelines; maintain required study registrations and documentation, as applicable; prepare for monitoring and audit activities; assist with resolution of findings; and coordinate safety monitoring and reporting requirements when applicable to individual…