Research Support Manager 2

Company: University of Minnesota
Location: Minneapolis
Posted on: February 25, 2021

Job Description:

The UMN has suspended hiring for most positions. However, we will continue hiring for positions critical to the University's mission and operations at this time. Applications are being accepted for this position and you are encouraged to apply. In-person interviews are suspended indefinitely and will be replaced by interviews in a virtual format. Thank you for your continued interest in working at the University of Minnesota. Qualifications Required Qualifications:
- Requires BA/BS with at least eight (8) years of experience or advanced degree with six (6) years of experience:
- At least four (4) years must include supervisory experience
- At least 5 years of clinical experience
- Current clinical degree/certification in clinical research and a strong understanding of clinical workflows.
- Extensive experience with clinical and/or translational research processes in an academic research setting preferably in women's health.--
- Knowledge of clinical research regulations and guidance, the Code of Federal Regulations, ICH GCP, and HIPAA regulations.
- Certification as a Clinical Research Professional
- 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.

Preferred Qualifications:
- Experience working in a CTSI/CTSA/CTO or similar research infrastructure system in a large organization.
- Familiarity with the University of Minnesota M Health Fairview system (Fairview, University of Minnesota Physicians).
- Experience working with EPIC and OnCore.
- Experience in women's health. About the Job

The Department of OB/GYN is charged with increasing high quality and efficient support for human subjects research. This new position will serving the entire department of OB/GYN at the University of Minnesota. The Research Director position will be responsible for partnering 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 in the Department. To this end, the Director will provide operational and strategic support for all divisions in OB/GYN.

The purpose of this role is to work collaboratively with investigators to identify gaps in the portfolio, develop relationships with industry and grow the clinical research programs within each division. The program director will be responsible for:
1. Leading and directing the day to day workload activities for the staff within the research services department.
2. Planning and implementation of resourcing needs required to advance clinical research and assisting investigators in gaining access to respective resources. This includes identification and coordination of internal and external stakeholders (e.g., biostatistics, recruitment, informatics consulting, regulatory, finance, data management, study coordination, outside industry sponsors, cooperative groups, University consortiums, etc.).
3. Utilizing extensive knowledge and comprehension of Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, and National Institute of Health (NIH) research rules to oversee portfolio activities, and applying them to the design, conduct, performance, monitoring, recording, analysis and reporting of clinical trials to the protecting the safety and health of human subjects and to meet--regulatory compliance requirements.
4. Strategizing, developing and implementing individual clinical research project plans including trial timelines, regulatory pathways, budgeting and contracting plans for the life cycle of the clinical trial.
5. Organizing and leading monthly ORC meetings to discuss ongoing research projects, finances and growth opportunities.

Essential Responsibilities Include:

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.--
- Develop and improve workflows and processes for conducting clinical research in the M Health Clinics and Surgery Center (CSC), Riverside Professional Building, and other M Health and community-based clinics. Improve navigability and integration of research into operations for researchers, research staff, clinicians and patients.
- Optimize recruitment of clinical trials into 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 the CTO and CTSI to further the broad integration of research into clinical operations.
- 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 the Department of OB/GYN.
- Oversee all research services. Refine service offerings, policies, and procedures to ensure compliance, promote efficiency, enhance user satisfaction, and improve research efficiency and effectiveness.
- 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 research program that supports a broad range of clinical research studies. Ensure researcher feedback. 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 (M Health, 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 Vice Chair of Research and Director of Clinical Trials
- Provide strategic direction for the clinical research portfolio in OB/GYN. 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 metrics. Participate in drafting progress reports and associated data requests.
- Hire and guide the onboarding of new research employees; provide daily work direction; supervise work to ensure timely and quality deliverables; coach and develop staff. Establish an environment that is motivating and engaging, and that provides employees with opportunities for skill acquisition, training, and professional development.--
- Promote a collaborative environment recognizing the investigators, research staff and subjects all as valued entities. Monitor group productivity, safety, and 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 the Department of OB/GYN in interactions with Departments, University Groups, Health System Partners & Affiliates, CTSA network and Community/External Organizations.
- Proactively identify opportunities to eliminate redundancies, optimize organizational structure, share best practices, and standardize processes.
- Other duties as assigned. About the Department The Department of Obstetrics, Gynecology, and Women's Health at the University of Minnesota is home to around 37 faculty, whose scholarship, teaching, and clinical practice spans across the sub-specialties in Obstetrics, Gynecology, and Women's Health. The department aims to accelerate the process of translating laboratory discoveries into treatments for patients, to engage all divisions in clinical research efforts, and to train a new generation of clinical and translational researchers. Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume. Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section. To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-UOHR (8647). Diversity The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu. Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment. About the U of M

The University of Minnesota, Twin Cities (UMTC) The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations. The University of Minnesota offers a--comprehensive benefits package, including:

• 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

Keywords: University of Minnesota, Minneapolis , Research Support Manager 2, Executive , Minneapolis, Minnesota