Research Services Program Manager

About the Role

The Division of Plastic and Reconstructive Surgery is seeking a motivated, passionate, and self-driven individual for a full-time Clinical Science Research Program Manager position. This role assists faculty and residents with clinical trials research, develops a clinical research program, and supervises the clinical research team within the division. Responsibilities include patient-oriented research, therapeutic interventions, clinical trials, epidemiological and behavioral studies, outcomes research, and health services research.

Clinical Science Research Program Managers act as work/team leads for 2 or more FTE Professionals, operate as Clinical Research Nurses (RN), or serve as subject matter experts (SMEs) in a specific area, possessing deep knowledge and oversight of processes, functions, and/or technologies.

Responsibilities

• Lead and direct the day-to-day operations of clinical trials and studies.
• Train coordinators, students, and research residents across multiple hospital locations (UCH, HRH, and CHCO) in:
  • Collecting study subjects' medical history and current medication information.
  • Reviewing research protocol inclusion/exclusion criteria and confirming subject eligibility.
  • Performing or ensuring the informed consent process is properly documented.
  • Interviewing prospective subjects and educating them on study details.
  • Scheduling subject participation and coordinating necessary resources (e.g., space, clinical support).
  • Collecting, coding, and analyzing data accurately and timely.
• Adhere to research regulatory standards and maintain detailed records for compliance with FDA, study protocols, and other guidelines.
• Participate in subject recruitment efforts, including pre-screening and screening activities.
• Ensure necessary supplies and equipment for studies are in stock and functional.
• Master study materials, including protocols, informed consent forms, and essential study documents.
• Independently perform study-related processes, procedures, and assessments in compliance with regulating bodies.
• Create and implement processes, procedures, and quality improvement initiatives.
• Develop protocol-specific systems and documents, such as process flows, training manuals, SOPs, and CRFs.
• Identify, analyze, and lead improvements in operational workflows to enhance efficiency, data quality, and regulatory compliance.
• Lead feasibility assessments and develop data-driven recruitment and retention strategies.
• Serve as lead in study initiation and close-out duties.
• Oversee and provide leadership to team members, including managing priorities, redistributing workloads, and mentoring staff across multiple sites.
• Provide input on team members' performance, evaluations, and development opportunities.
• Complete annual performance reviews for all clinical research staff in the division.
• Identify training and development opportunities for team members.
• Act as a Subject Matter Expert (SME) in clinical research.
• Develop and manage study budgets, ensuring financial feasibility and compliance.

Additional Duties

• Study Coordination:
  • Coordinate clinical research visits and collect/record data with direct patient contact.
  • Determine feasibility, recruitment, and retention strategies; implement innovative solutions.
  • Manage IRB submissions, including initial applications, amendments, and reportable events.
• Data and Database Management:
  • Review research proposal submissions for the division.
  • Conduct literature reviews for investigators.
  • Collect, code, and analyze data accurately and timely.
  • Maintain study protocols in OnCore.
  • Perform data entry, survey creation, and organization in REDCap and OnCore.
• Designing and Execution of Research Projects:
  • Lead project planning, data interpretation, and team presentations.
  • Serve as a resource for study initiation and close-out duties.
• Team Collaboration:
  • Serve as a primary liaison across investigators, clinical teams, sponsors, CROs, and institutional departments.
  • Provide excellent customer service to internal and external stakeholders.
  • Assist residents and medical students with abstract and manuscript writing.
  • Oversee and track research productivity, including abstracts, manuscripts, and conference presentations.
  • Communicate research findings during team meetings.
• Supervision:
  • Supervise research services professionals, medical students, and research fellows, including delegating responsibilities, conducting performance reviews, and tracking leave.

Qualifications

• Minimum Qualifications:
  • Bachelor’s degree in science or health-related field (e.g., Biology).
  • Four (4) years of clinical research or related experience in an academic setting.
  • Experience with research database management.
  • Substitution: A combination of education and related technical/paraprofessional experience may substitute for the bachelor’s degree on a year-for-year basis.
• Preferred Qualifications:
  • Five+ (5+) years of clinical research or related experience in an academic setting.
  • Supervisory experience.
  • Exceptional interpersonal communication skills.

Skills

• Ability to communicate effectively, both in writing and orally.
• Ability to establish and maintain effective working relationships at all levels.
• Outstanding customer service skills.
• Demonstrated commitment and leadership in advancing diversity and inclusion.
• Advanced knowledge of federal regulations and Good Clinical Practice (GCP).
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.
• Expert-level knowledge of clinical research processes.

Schedule

Hybrid – 3 days in-person and 2 days remote per week on campus, with additional in-person meetings as needed in Aurora, CO.

Benefits

• Medical: Multiple plan options.
• Dental: Multiple plan options.
• Additional Insurance: Disability, Life, Vision.
• Retirement 401(a) Plan: Employer contributes 10% of gross pay.
• Paid Time Off:
  • Vacation Days: 22/year (maximum accrual 352 hours).
  • Sick Days: 15/year (unlimited maximum accrual).
  • Holiday Days: 15/year.
• Tuition Benefit: Accessible on all CU campuses.
• ECO Pass: Reduced rate RTD Bus and light rail service.

Pay

The starting salary range for this position is $70,446 - $94,398. This position may be eligible for overtime compensation.