UNIV - Research Program Assistant - Psychiatry: ASD

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 studies.

20% – Financial and Administrative Coordination: Facilitate development, review, and monitoring of study budgets, invoices, subcontracts, and billing activities related to research studies. Collaborate with grants administration and other institutional offices to monitor study expenditures and effort reporting; assist with grant-year and study closeout activities; coordinate procurement and study-related purchasing; track research resources and operational needs; and provide administrative coordination related to PI scheduling, research meetings, and research travel.

5% – Strategic and Analytical Support: Assist with operational reporting, recruitment tracking and projections, study progress summaries, and preparation of materials supporting grant applications, manuscripts, presentations, sponsor reports, and study progress reporting. Assist the PI in identifying operational requirements for proposed studies and translating study protocols and research plans into feasible workflows and implementation procedures.

5% – Data and Quality Oversight: Coordinate study data tracking and data workflows to support completeness, accuracy, protocol adherence, and timely study updates. Assist with development and maintenance of data collection forms, databases, and data quality procedures; monitor study documentation and data for completeness and consistency; coordinate resolution of data issues; and ensure maintenance of required study certifications and training documentation for research personnel.

5% – Study Startup and Research Infrastructure Support: Support startup of new research studies and establishment of the operational infrastructure needed for the newly established lab. Assist with preparation of Just-in-Time (JIT) materials, regulatory startup documentation, site activation materials, study-specific process flows, training materials, and other operational documents. Support implementation of shared systems for study documentation, equipment and supply management, staff onboarding, research workflows, and coordination across studies to facilitate efficient study initiation and ongoing research operations.

Preferred Training & Experience: Experience coordinating clinical research studies and working with research staff is desired. 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, given the lab’s research collaborations in Brazil.

Additional Job Description

Minimum Requirements: A high school diploma and four years of relevant program experience. A bachelor's degree may be substituted for the required 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. (Continuous) 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 lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent) Ability to lower objects, u