UNIV - Program Manager I - Psychiatry: Addiction Sciences Division

musc; Charleston (SC); On-site; USD 66,000 - 120,000; Full time

Job summary

Medical University of South Carolina (MUSC - Univ) in Charleston seeks a Clinical Research Program Manager to oversee operations across a growing portfolio of multi-site clinical trials and federally funded studies.

The role provides operational leadership, regulatory oversight, budget tracking, staff development, and process improvements across collaborating institutions and PI teams.

Qualifications

• 5+ years of experience in clinical research program management.
• Experience coordinating multi-site trials and supervising staff.
• Experience with regulatory oversight (FDA/IRB) and GCP guidelines.

Responsibilities

• Provide operational oversight for multiple federally funded clinical studies and multisite coordination across collaborating institutions.
• Lead staff management including hiring, onboarding, training, and development; oversee recruitment processes.
• Coordinate preparation of study protocols, regulatory submissions, and documentation; ensure compliance and audits.

Skills

Clinical trial operations

Multisite coordination

Staff management

Regulatory compliance

Budgeting & finance

Grant administration

Education

MPH or related graduate degree

Job description

Job Description Summary

Team Impact within the Department of Psychiatry is seeking a highly organized and experienced Clinical Research Program Manager to oversee operations across a growing portfolio of large-scale clinical trials and multi-site research studies.

This position will provide operational leadership for multiple federally funded clinical research studies conducted across several collaborating institutions. The Program Manager will work closely with Principal Investigators and research staff to support study execution, staff management, regulatory oversight, multisite coordination, budget tracking, and operational infrastructure development.

The ideal candidate is an experienced clinical research professional with strong leadership, regulatory, and organizational skills who is comfortable managing complex workflows across multiple concurrent studies.

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

Salary

Pay Grade

University-GEN11

Pay Range

66,400.00 - 92,900.00 - 119,500.000

Scheduled Weekly Hours

40

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