UNIV - Research Program Assistant - Psychiatry: ASD
About The Position
The Freitas-Lemos Lab in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina seeks a highly organized and experienced clinical research professional to support operations across a growing portfolio of pilot studies, clinical research studies, and multisite collaborations. Working closely with the Principal Investigator, the position will help build the operational infrastructure for a newly established lab and coordinate studies at different stages of development and implementation. The role coordinates study startup, implementation, maintenance, and closeout; develops research workflows, standard operating procedures, training materials, and documentation systems; supports staff coordination and regulatory compliance; and facilitates data, biospecimen, budget, and administrative workflows. It also supports collaboration with research sites and institutional offices, operational reporting, and the establishment of shared systems for efficient research operations. The position may assume formal supervisory responsibilities for other research staff over time.
Requirements
- High school diploma and four years of relevant program experience; a bachelor's degree may be substituted for the required program experience.
- Experience coordinating clinical research studies and working with research staff is desired.
- Ability to perform the physical functions described in the posting, including frequent seated, upright, and mobile work; continuous indoor work and use of both hands/arms; and occasional lifting, carrying, pushing, or pulling objects up to 15 pounds.
Nice To Haves
- Experience with multisite research.
- Experience developing or implementing research workflows.
- An MPH or other relevant graduate degree.
- Portuguese language proficiency; desirable but not required.
Responsibilities
- Coordinate startup, implementation, maintenance, and closeout for pilot studies, clinical research studies, and multisite collaborations.
- Develop and maintain study workflows, standard operating procedures, training materials, and documentation systems.
- Coordinate recruitment, screening, study visits, and participant tracking; monitor study progress, recruitment, staffing needs, and visit forecasts.
- Oversee study supplies, equipment, investigational products when applicable, and biospecimen collection, processing, storage, and shipping workflows.
- Facilitate operational communication with collaborating investigators and research sites, identify bottlenecks, and implement process improvements.
- Coordinate day-to-day research activities and communication among staff, trainees, investigators, and collaborators.
- Support personnel onboarding and training, team meetings, task assignment and tracking, and recruitment and onboarding of new staff.
- Coordinate preparation and submission of protocols, consent forms, amendments, continuing reviews, and other regulatory applications; maintain regulatory and training documentation.
- Coordinate IRB communications and timelines, study registrations when applicable, monitoring and audit preparation, resolution of findings, and applicable safety monitoring and reporting.
- Facilitate development, review, and monitoring of study budgets, invoices, subcontracts, and billing; monitor expenditures and effort reporting with institutional offices.
- Assist with grant-year and study closeout, procurement, study-related purchasing, resource tracking, PI scheduling, research meetings, and research travel.
- Support operational reporting, recruitment tracking and projections, study progress summaries, and materials for grants, manuscripts, presentations, sponsor reports, and progress reporting.
- Assist the PI in identifying operational requirements for proposed studies and converting protocols and research plans into feasible workflows.
- Coordinate data tracking and workflows; support data collection forms, databases, quality procedures, completeness and consistency checks, and resolution of data issues.
- Support study startup and lab infrastructure, including JIT materials, regulatory startup documentation, site activation materials, process flows, training materials, and shared operational systems.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
