Clinical Research Ops Manager – Multi-Site Trials

Medical University of South Carolina; Orleans Estates (SC); On-site; USD 66,000 - 120,000; Full time

Job summary

Medical University of South Carolina (MUSC - Univ) is seeking a Clinical Research Program Manager to oversee operations across a growing portfolio of large-scale clinical trials and multi-site studies. You will collaborate with Principal Investigators to drive study execution, regulatory compliance, staffing, and infrastructure development.

The role emphasizes leading cross-site coordination, budget oversight, SOP development, and process improvements while managing a team of investigators,

Qualifications

• Five years relevant program experience.
• Experience coordinating multi-site trials and supervising staff.
• An MPH or other graduate degree.
• A bachelor's degree and three years relevant program experience.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Assist with operational reporting, data summaries, recruitment projections, and preparation of materials supporting grant applications, manuscripts, and study progress reporting.
• 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.
• 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.

Skills

Staff management

Regulatory oversight

Multisite coordination

Budget tracking

Process improvement

Leadership

Grant administration

Education

Bachelor's degree

MPH or graduate degree

Job description

Medical University of South Carolina (MUSC - Univ) is seeking a Clinical Research Program Manager to oversee operations across a growing portfolio of large-scale clinical trials and multi-site studies. You will collaborate with Principal Investigators to drive study execution, regulatory compliance, staffing, and infrastructure development.

The role emphasizes leading cross-site coordination, budget oversight, SOP development, and process improvements while managing a team of investigators,