Research Services Program Manager

Research Services Program ManagerThe 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 to assist faculty and residents with clinical trials research, developing a clinical research program and supervising the clinical research team within the division.Clinical Science Research Program Managers perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Research Program Managers may also assist with epidemiological and behavioral studies and/or outcomes research and health services research. Clinical Science Research Program Managers either act as work/team leads for 2 or more FTE Professionals, operate as Clinical Research Nurses (RN), or are the subject matter experts (SME) in a particular area.

SMEs possess a deep knowledge and oversight of a specific process, function and/or technology. SMEs are considered an authority in the area and are educated on the subject and are also able to share their knowledge with other stakeholders. Some Assignments will not move beyond this level.Example of Duties PerformedLead and direct the day-to-day operations of clinical trials and studiesPerform as well as responsible for training all coordinators, students and research residents for multiple hospital locations (UCH, HRH and CHCO) in the following:Collecting study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trialPerforming informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as requiredInterviewing prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviewsScheduling subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)Collecting, coding, and analyzing data obtained from research in an accurate and timely mannerAdhering to research regulatory standardsMaintaining detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelinesParticipating in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activitiesEnsuring that the necessary supplies and equipment for studies are in stock and in working orderIndependently mastering study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studiesIndependently performing study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodiesCreation and implementation of processes and procedures and quality improvement initiativesActing as a Primary Coordinator on multiple trials/studiesLeading the development, implementation, and continuous improvement developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs) that meet the requirements of study protocols, and research regulations and best practices (e.g., ICH guidelines, FDA code of Federal Regulations, and Good Clinical Practice (GCP))Identifying, analyzing, and leading improvements in operational workflows to enhance efficiency, data quality, and regulatory compliance; communicating findings and strategic recommendations to leadershipLeading feasibility assessments and develop data-driven recruitment and retention strategies; designing, implementing, and evaluating innovative approaches to optimize study enrollment and participant engagementServing as lead in study initiation and close out dutiesOverseeing and providing leadership to the team members, including managing day-to-day priorities, evaluating and redistributing workloads on a temporary basis, and mentoring staff across multiple sites and hospitals (UCH, HRH and CHCO)Providing input and feedback to leadership on team members' overall performance, performance evaluations, opportunities for development, and process improvement initiativesCompleting annual performance reviews on all clinical research staff in the divisionIdentifying training and development opportunities for new and existing team membersActing as a Subject Matter Expert (SME) and authority in the area(s) of clinical research.

Developing and managing study budgets, ensuring financial feasibility, appropriate cost recovery, and alignment with institutional billing compliance and sponsor requirementsAdditional Duties & ResponsibilitiesStudy CoordinationCoordinate clinical research visits and collecting/recording data. This position includes comprehensive direct patient contact with a high-level of ethics and integrity.Collect information to determine feasibility, recruitment, and retention strategies.Employ, evaluate, and assist with the implementation of innovative solutions to maximize recruitment and retention.Coordinate and manage IRB submissions for study protocols, including initial applications, amendments, and reportable events, ensuring compliance with institutional and federal requirementsData and Database ManagementReview research proposal submission for the division.Conduct literature reviews for investigators.Collect, code, and analyze data obtained from research in an accurate and timely manner.Open and maintain study protocols in OnCore.Data entry, survey creation, and organization, and retrieval of data for research projects in REDCap and OnCore.Designing and execution of research projects and analysis of dataLead project planning, data interpretation and team presentationsServe as a resource and participate in study initiation and close out duties.Team CollaborationServe as a primary liaison across investigators, clinical teams, sponsors, CROs, and institutional departments, facilitating cross-functional collaboration and ensuring efficient study execution across all phases.The research services professional is responsible for providing excellent customer service to both internal and external stakeholders by presenting a positive image of the department and University.Assist residents, medical students with abstract and manuscript writing.Oversee and track research productivity across the division, including abstracts, manuscripts, and conference presentations for faculty, residents, and trainees.Communicate the research findings with the team during meetings when required.SupervisionThis position would be responsible for the supervision of research services professionals, medical students, and research fellows including job responsibilities delegation, annual performance reviews, and leave tracking/approval.Work Location: Hybrid – this role is eligible for a hybrid schedule of 3 days in-person/2 days remote per week on campus and as needed for in-person meetings in Aurora, CO.Why Join Us: The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans.In addition, the Anschutz Campus has also been recognized as an Age-Friendly University.

The University of Colorado is committed to diversity and equality in education and employment.Why work for the University? We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:Medical: Multiple plan optionsDental: Multiple plan optionsAdditional Insurance: Disability, Life, VisionRetirement 401(a) Plan: Employer contributes 10% of your gross payPaid Time Off: Accruals over the yearVacation Days: 22/year (maximum accrual 352 hours)Sick Days: 15/year (unlimited maximum accrual)Holiday Days: 15/yearTuition Benefit: Employees have access to this benefit on all CU campusesECO Pass: Reduced rate RTD Bus and light rail serviceThere are many additional perks & programs with the CU AdvantageQualificationsMinimum Qualifications:Bachelor's degree in science