UNIV - Program Manager I - Psychiatry: Addiction Sciences Division
About The Position
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.
Requirements
- A bachelor's degree and three years relevant program experience.
Nice To Haves
- Five years relevant program experience.
- Experience coordinating multi-site trials and supervising staff.
- An MPH or other graduate degree.
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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
