UNIV - Research Program Assistant - Psychiatry: ASD

Medical University of South Carolina•Charleston, SC

10d

About The Position

The Freitas-Lemos Lab in the Department of Psychiatry and Behavioral Sciences is seeking a highly organized, experienced clinical research professional to support operations across a growing portfolio of clinical research studies, including pilot studies and multisite collaborations. As a newly established lab at MUSC, the position works closely with the Principal Investigator to develop operational infrastructure and coordinate studies at different stages of development and implementation. The role supports study startup, implementation, maintenance, and closeout; research workflows and standard operating procedures; staff coordination; regulatory activities; data and biospecimen workflows; coordination with collaborating institutions; and budget and administrative tracking. It also contributes to operational reporting, data quality, research infrastructure, and the development of efficient systems for a growing research program. The position is hourly, scheduled for 40 hours per week, Monday through Friday, 8:30 a.m. to 5:00 p.m. Over time, it may assume formal supervisory responsibilities for other research staff.

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.
Strong organizational, regulatory, and leadership skills; comfort establishing research processes and coordinating multiple concurrent studies and collaborations.

Nice To Haves

Experience with multisite research and developing or implementing research workflows is preferred.
An MPH or other relevant graduate degree is desired.
Portuguese language proficiency is desirable but not required.

Responsibilities

Coordinate operations across pilot studies, clinical research studies, and multisite collaborations, including study startup, implementation, maintenance, and closeout.
Develop and maintain study workflows, standard operating procedures, training materials, and documentation systems.
Coordinate recruitment, screening, study visits, participant tracking, supplies, equipment, investigational products when applicable, and biospecimen collection, processing, storage, and shipping workflows.
Facilitate operational communication with collaborating investigators and research sites; monitor study progress, recruitment, staffing needs, and visit forecasting; identify bottlenecks and implement process improvements.
Coordinate day-to-day research activities and communication among research staff, trainees, investigators, and collaborators; support onboarding and training, team meetings, task assignment and tracking, and recruitment and onboarding of new staff.
Coordinate preparation and submission of study protocols, consent forms, amendments, continuing reviews, and other regulatory applications; maintain regulatory and training documentation and coordinate IRB communications and timelines.
Maintain study registrations and documentation as applicable; prepare for monitoring and audits, assist with resolving findings, and coordinate safety monitoring and reporting requirements when applicable.
Facilitate development, review, and monitoring of study budgets, invoices, subcontracts, and billing activities; work with grants administration and institutional offices to monitor expenditures and effort reporting and assist with grant-year and study closeouts.
Coordinate procurement and research-related purchasing, track resources and operational needs, and provide administrative support for PI scheduling, research meetings, and research travel.
Assist with operational reporting, recruitment tracking and projections, study progress summaries, and materials for grant applications, manuscripts, presentations, sponsor reports, and study progress reporting.
Help identify operational requirements for proposed studies and translate protocols and research plans into feasible workflows and implementation procedures.
Coordinate data tracking and workflows; assist with data collection forms, databases, and data quality procedures; monitor data and documentation for completeness and consistency and coordinate resolution of data issues.
Support startup of new studies and establishment of lab infrastructure, including JIT materials, regulatory startup documentation, site activation materials, process flows, training materials, and shared systems for documentation, supplies, equipment, onboarding, and research workflows.
Ensure maintenance of required study certifications and training documentation for research personnel.