Univ) Worker Type Employee Worker Sub-Type Research Grant Cost Center

CC001039 COM PSYCH

Addiction Science CC Pay Rate Type Salary Pay Grade University-GEN11 Pay Range 66,400.00

92,900.00
119,500.

000 Scheduled Weekly Hours 40

Work Shift Job Description FLSA:

Salary Work Schedule:

Monday

Friday, 8:30 am
5:00 pm, flexibility to cover evening and weekends as necessary

Job Duties:

30%•

Clinical Trial Operations and Multisite Coordination:

Provide operational oversight across multiple clinical trials and collaborating research sites. Coordinate study startup, maintenance, and closeout activities; oversee multisite communication, data flow, biospecimen logistics, and study timelines; develop and maintain standard operating procedures (SOPs); identify operational bottlenecks and implement process improvements; monitor study progress, staffing needs, and visit forecasting across studies. 20%•

Staff Management and Operational Leadership:

Coordinate day-to-day activities of research staff members and collaborate with a broader team of over 20 investigators, trainees, interns, and collaborators across multiple studies and sites. Lead hiring, onboarding, training, and staff development activities. Manage position postings and recruitment processes, including development of job descriptions, position requests, matrix submissions, interviews, Certification, Education, and Experience Worksheets, and staff reclassifications. Over time, the candidate may take on official supervision responsibilities for other staff members. 15%•

Regulatory and Compliance Oversight:

Coordinate preparation and submission of study protocols, consent forms, and regulatory applications. Maintain accurate and comprehensive study documentation in compliance with FDA regulations, Institutional Review Board (IRB) requirements, sponsor expectations, and Good Clinical Practice (GCP) guidelines. Coordinate eIRB/IRB communications, support audits and monitoring visits, oversee regulatory timelines, and coordinate Data Safety Monitoring Board (DSMB) meetings and reporting activities. 20%•

Financial and Administrative Coordination:

Facilitate development, review, and monitoring of study budgets, invoices, subcontracts, and billing activities related to clinical research studies. Collaborate with grants administration to monitor study expenditures and effort reporting; assist with grant year closeout activities; oversee procurement and study-related purchasing; and provide administrative coordination related to PI scheduling and research travel. 5%

Strategic and Analytical Support:
Assist with operational reporting, data summaries, recruitment projections, and preparation of materials supporting grant applications, manuscripts, and study progress reporting. 5%

•

Data and Quality Oversight:

Oversee study data tracking and cross-site coordination to ensure data completeness, protocol adherence, and timely study updates across collaborating institutions. Monitor study documentation for compliance with protocols, SOPs, and applicable federal, state, and local regulations. Ensure maintenance of required study certifications and training documentation for research personnel. 5%•

Study Startup and Research Infrastructure Support:

Support study startup activities, including preparation of Just-in-Time (JIT) materials, regulatory startup documentation, site activation materials, and operational infrastructure necessary to meet study initiation timelines and sponsor requirements.

Preferred Training & Experience:

Five years relevant program experience. Experience coordinating multi-site trials and supervising staff. An MPH or other graduate degree.

Additional Job Description Minimum Requirements :

A bachelor's degree and three years relevant 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. (Frequent) 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 push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent) If you like working with energetic enthusiastic individuals, you will enjoy your career with us! The Medical University of South Carolina is an Equal Opportunity Employer. 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UNIV - Program Manager I - Psychiatry: Addiction Sciences Division