Clinical Research Operations Director CTRS
Clinical and Translational Research Services (CTRS) is charged with providing high quality and efficient support for human subjects research, serving the entire clinical and translational research enterprise at the University of Minnesota. The CTRS Operations Director is part of the strategic leadership of CTRS, under the direction of the CTRS Director and Associate Director. The CTRS Operations Director partners with M Health (Fairview Health Services and University of Minnesota Physicians Group (UMP)) and other affiliated healthcare providers/systems to improve the integration of research into clinical operations and patient care activities. To this end, the Operations Director provides operational and strategic leadership for a variety of research services in the CTRS core. This position will also represent the Clinical & Translational Science Institute (CTSI) and the University of Minnesota to further institutional and partner collaborative initiatives, including the CTSA Trial Innovation Network and the MARCH Consortium.
Integration of Research into Clinical Operations and Patient Care Activities (30%)
Partner with M Health (Fairview Health Services and University of Minnesota Physicians Group (UMP)) and other affiliated healthcare providers/systems to improve the integration of research into clinical operations and patient care activities.
● Improve workflows and processes for conducting clinical research in the M Health Clinics and Surgery Center (CSC) and community-based clinics. Improve navigability and integration of research into operations for researchers, research staff, clinicians and patients.
● Optimize recruitment activities within M Health and other affiliate/partner health systems. Improve patient and clinician awareness of clinical research opportunities. Identify and eliminate barriers to recruitment, screening and enrolling clinical research participants.
● Collaborate with other CTSI functions, e.g., CEARCH and Informatics, to further the broad integration of research into clinical operations.
● Cooperate in planning efforts for the future Clinical Research Facility
● Drive research awareness initiatives across the health system.
● In collaboration with clinical partners, serve in a leadership role for the M Health Clinical Research Unit, utilizing research expertise and institutional context to support decision making and ensure alignment with CTSI initiatives.
Program Development and Implementation (30%) - Provide strategic direction and leadership in the development and delivery of research service programs and initiatives within CTSI.
● Oversee the Clinical and Translational Research Service operations to provide high quality research services. Refine service offerings, policies, and procedures to ensure compliance, promote efficiency, enhance user satisfaction, and improve research efficiency and effectiveness. Ensure engaged staff involvement, as appropriate, in the Clinical Research Support Center (CRSC) and Parallel Processing initiatives.
● Establish and modify existing programs to assist researchers in efficient clinical research study startup and initial enrollment. Build comprehensive support services and tools, including: assistance in regulatory application & approvals, feasibility assessments, advising research teams on start-up activities, supporting the development of or participation in multi-site studies and pilot funding.
● Provide oversight for a robust, comprehensive CTRS program that supports a broad range of clinical research studies. Ensure researcher feedback, CTSA benchmarking and community/health systems input is represented in the strategic direction and planning for the CTRS. Oversee execution of programs and initiatives ensuring they are robust, ethical, inclusive, compliant, high quality, and meet the needs of stakeholders.
● Oversee programs to advance research awareness, engagement and participation in the Clinical/Community Health Systems (MHealth, Fairview, etc.).
● Oversee the design and implementation of programs that serve the entire clinical and translational research enterprise. Foster collaboration with institutional, health system and partner institutions and consortiums in order to build holistic programs. Work across the clinical research enterprise to identify gaps and implement process improvement initiatives to meet those development needs.
● Work with leaders across the University (Office of Vice President Research - OVPR, Institutional Review Board - IRB, OACA, Medical School Departments) to develop and implement new clinical research services/support opportunities as needed to address enterprise needs, promote regulatory compliance, and drive research effectiveness and efficiency.
Personnel and Operational Management (25%) - Provide leadership, directly and in collaboration with the functional managers, for the CTRS Operations group.
● Provide strategic direction for CTRS Operations team. Establish and communicate organizational priorities. Ensure appropriate alignment of organizational structure, resources and timelines to deliver organizational priorities. Identify and develop operational and programmatic metrics to evaluate team performance.
● Ensure alignment and tracking of operational as well as CTSA metrics. Participate in drafting CTSA progress reports and associated data requests.
● Hire and guide the onboarding of new employees; provide daily work direction; supervise work to ensure timely and quality deliverables; coach and develop staff. Establish an environment for the CTRS Operations group that is motivating and engaging, and that provides employees with opportunities for skill acquisition, training, and professional development.
● Promote a customer-centric and collaborative environment recognizing the investigators, research staff and subjects all as customers. Ensure CTRS Operations deliver quality and valued support. Monitor group productivity, service utilization, and user satisfaction. Identify and resolve issues/concerns. Implement operational changes that better support staff as they work with investigators to initiate, execute, and complete projects/trials/studies.
Institutional and Partner Collaborations (15%) - Represent Clinical Translational Research Services (CTRS) in interactions with Departments, University Groups, Health System Partners & Affiliates, CTSA network and Community/External Organizations.
● Participate as a key Hub Liaison Team member for the Trial Innovation Network (TIN), and represent CTRS with various research consortiums.
● Facilitate University of Minnesota participation in the Trial Innovation Network – identifying researchers for participation on TIN studies, and identifying opportunities for UMN researchers to leverage TIN resources.
● Work with Midwest Area Research Consortium (MARCH) administrative team and other consortium leads to establish operating processes and communication flows. Facilitate UMN participation on MARCH multi-site studies, and opportunities to leverage the MARCH network and resources on UMN-led multi-site trials. Perform similar activities with other multisite research collaboratives.
● Represent CTRS, or ensure appropriate representation from CTRS Operations, on University research initiatives. Collaborate with OVPR, OACA, Medical School Departments, HRPP and other Research Organizations/Centers (i.e. Clinical Trials Office) to improve the overall efficiency and effectiveness of the enterprise research services/support. Proactively identify opportunities to eliminate redundancies, optimize organizational structure, share best practices, and standardize processes.
Other duties as assigned.
● Requires BA/BS with at least ten (10) years of experience or advanced degree with eight (8) years of experience:
o At least four (4) years must include supervisory experience
o At least 5 years of clinical experience
● Current licensure as a Registered Nurse, Nurse Practitioner, Physician's Assistant or other applicable clinical degree/certification and an understanding of clinical workflows. Candidates without clinical degree/certification but with extensive experience working in clinical environments and with clinical workflows will also be considered.
● Extensive experience with clinical and/or translational research processes. Preferably in an academic research setting.
● Knowledge of clinical research regulations and guidance, the Code of Federal Regulations, ICH GCP, and HIPAA regulations.
● Certification as a Clinical Research Professional, or qualified to sit for the certification exam.
● Ability to work with individuals at all levels of the institution/organization, including senior level administrators, faculty, and staff.
● Excellent organizational and leadership skills. Strong written and oral communication skills.
● Experience working in a CTSI/CTSA or similar research infrastructure system in a large organization.
● Familiarity with the University of Minnesota MHealth system (Fairview, University of Minnesota Physicians).
● Experience working with EPIC and OnCore.
● Experience in leading and facilitating operational and cultural change in an organization.