UNIV - Program Manager I - Psychiatry: Addiction Sciences Division

Job Duties

• 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.
• Career Management and Operational Leadership:
  • 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.
• 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.
  • Coverage of eIRB/IRB communications, support audits and monitoring visits, oversee regulatory timelines, and coordinate Data Safety Monitoring Board (DSMB) meetings and reporting activities.
• 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.
• Strategic and Analytical Support:
  • Aid in operational reporting, data summaries, recruitment projections, and preparation of materials supporting grant applications, manuscripts, and study progress reporting.
• 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.
• 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.

Minimum Requirements

• A bachelor's degree and three years relevant program experience.
• Ability to perform job functions in an upright position.
• Ability to perform job functions in a seated position.
• Ability to perform job functions while walking/mobile.
• Ability to work indoors.
• Ability to work outdoors in all weather and temperature extremes.
• Ability to work in confined/cramped spaces.
• Ability to perform job functions from kneeling positions.
• Ability to squat and perform job functions.
• Ability to perform 'pinching' operations.
• Ability to fully use both hands/arms.
• Ability to perform repetitive motions with hands/wrists/elbows and shoulders.
• Ability to reach in all directions.
• Possess good finger dexterity.
• Ability to maintain tactile sensory functions.
• Ability to lift and carry 15 lbs., unassisted.
• Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted.
• Ability to push/pull objects, up to 15 lbs., unassisted.
• Ability to maintain 20/40 vision, corrected, in one eye or with both eyes.
• Ability to see and recognize objects close at hand.
• Ability to see and recognize objects at a distance.
• Ability to match or discriminate between colors.
• Ability to determine distance/relationship between objects; depth perception.
• Good peripheral vision capabilities.
• Ability to maintain hearing acuity, with correction.
• Ability to hear and/or understand whispered conversations at a distance of 3 feet.
• Ability to perform gross motor functions with frequent fine motor movements.
• Ability to work in dusty areas.