Clinical Director, Cell, Gene and Immunotherapy in the Masonic Cancer Center (MCC) Clinical Trials Office (CTO-CGI)
Research Nurse Manager 2 - Job Code 93542
The CTO-CGI Clinical Director is responsible for the development and implementation of strategic planning goals and initiatives for CTO-CGI clinical research. The position oversees the implementation and ongoing-maintenance of clinical trials by clinical research coordinators and nurses assigned to the various disease teams, ensuring full compliance with local, state, and federal policies and procedures.
Participate in long-range development, including strategic growth planning, supporting CTO-CGI clinical investigations.
Work closely with the CTO-CGI medical director, CTO-CGI Operations Director, CTO-Solid Tumor Clinical Director and the MCC Executive Administrative Director to ensure alignment with system and leadership goals (MCC, MHealth, UMN).
Serve as a member of the Center’s Clinical Research Leadership team to participate in development of research priorities and the resources necessary to accomplish the Center's mission.
Partner with other offices and committees within the University of Minnesota, Academic Health Center, Clinical Translational Science Institute, University of Minnesota Physicians, and Fairview to facilitate and make recommendations for optimizing clinical research, research compliance, and patient experience.
Represent MCC in the development and implementation of AHC-wide clinical research policies and procedures.
Collaborate with principal investigators, faculty and MCC leadership/administration to promote and support a comprehensive portfolio of investigator-initiated and industry-sponsored Phase I-III trials.
Clinical Program Oversight:
Develop, implement, monitor and report on clinical processes and procedures to ensure that services are provided to clinical investigators in an efficient, integrated and high quality manner to meet the CTO-CGI Program’s clinical and research objectives.
Create and drive clinical process improvement and standardization across CTO-CGI for clinical trial management.
Lead the clinical research team in developing, implementing and delivering the cross-functional clinical strategy for CTO-CGI supported clinical trials.
Conduct ongoing analysis and evaluation of clinical research activities, developing and implementing corrective action plans as required with CTO staff, clinical care teams, research investigators and MCC leadership.
Ensure that all CTO clinical-related policies and procedures are reviewed annually and kept current in accordance with local, state and federal regulations and standards.
Ensure clinical research documentation and protocol compliance are maintained at high standards, consistent with local, state, federal and industry monitoring / auditing requirements and other research regulations, including the MCC Data Safety Monitoring Plan.
Act as reviewer and/or approver for clinical SOPs or cross-functional SOPs owned by other operations.
Establish and facilitate relationships with other managers, faculty, and staff to ensure effective administration of clinical trials, actively addressing issues with overall study management from a clinical perspective.
Maintain up-to-date knowledge and comprehension of Code of Federal Regulations (CRF) Good Clinical Practice GCP) guidelines and National Institutes of Health (NIH) research rules that define conduct, performance, monitoring, auditing and reporting for CTO clinical trials.
Provide clinical guidance and support to MCC faculty and other clinical research staff.
Collaborate with UMP and FV management to ensure CTO-CGI processes and workflows are in alignment with clinical partners’ workflows and processes.
Represent the CTO in interactions with the FDA and any other regulatory authorities.
Manage and Lead Clinical Personnel:
Clinical Personnel: ~20 FTEs
(1 FTE) Research Nurse Supervisor
(~7 FTE) Research Nurses
(1 FTE) Clinical Research Coordinator Supervisor
(~11 FTE) Clinical Research Coordinators
Foster an environment of excellence that supports the mission, vision, values, goals and objectives of CTO and MCC.
Manage and/or oversee the CTO-CGI personnel management and training of all non-physician clinical research staff, ensuring staff are working within their scope of practice.
Competitive wages, paid holidays, vacation and sick leave
Low cost medical, dental, and pharmacy plans
Health care and dependent daycare flexible spending accounts
Excellent retirement plans with employer match
Disability and employer paid life insurance
Wellbeing program with reduced insurance premiums
Tuition reimbursement opportunities covering 75%-100% of eligible tuition
Student loan forgiveness opportunity
Opportunities for growth and promotion
Employee Assistance Program
Bachelor’s degree in nursing with at least 8 years’ of combined clinical/clinical research/management experience, with at least 4 of those years being clinical research experience; or Advanced Practice Provider (NP or PA) and 4 years’ of clinical research experience. Current Licensure or certification, or eligibility for licensure or certification, in state of Minnesota.
Clinical or clinical research expertise in oncology, hematology, hematopoietic stem cell transplant or cellular/gene therapy/immunotherapy.
In depth knowledge of clinical research regulations governing the conduct of clinical trials and quality standards.
Prior supervisory experience overseeing a small department or cross-disciplinary/complex team.
Proficiency with clinical trials management software Microsoft Office and Google applications.
Proven excellent interpersonal and communication skills (oral & written) in a leadership or managerial role.
Demonstrated ability to lead strategic initiatives and focus on multiple deliverables simultaneously.
Demonstrated commitment to operational and clinical excellence.
Demonstrated strong leadership skills.
Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) certification.
Extensive knowledge and experience of clinical trial planning, management and metrics, clinical trial management systems (CTMS) and reporting tools.
Experience with or knowledge of budgets or finance concepts.
Familiarity and experience with the University of Minnesota, University of Minnesota Minimum Qualifications.
Internal Number: 328595
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.