Clinical Research Project Manager - Supervisor

In close partnership with the Clinical Research Director, this position is responsible for the research operations of a portfolio of research studies and a team of research staff. Research Project Managers are working managers, and duties include: assisting with the development of research studies, securing regulatory approvals, facilitating budget development and financial management, monitoring study accrual, and ensuring successful overall study coordination and compliance with applicable regulations and guidelines.

Major Duties/Job Description:

Clinical Trial Portfolio Management and Oversight (30%)

• Facilitate efficient and effective study start-up, which includes:
  • Determining billing designations, informing calendar build, ensuring accurate pricing and budget development; partner with CTFS for budget development and negotiation for industry-sponsored trials; partner with PedsRSS for grants and subawards
  • Ensuring IRB and other regulatory approvals; partner with Regulatory Specialists for effective and efficient regulatory process and complete documents
  • Collaborate with clinical partners to establish study logistics, including specimen collection and management, investigational product management, clinical procedures, etc.
  • Serve as point person for faculty investigators and research sponsors; build effective relationships that promote research ethics and high quality research in children
  • Facilitating effective project planning and start-up for investigator-initiated research following federal regulations and local policies.
• Ensure compliance with University requirements for registering research projects, obtaining ancillary reviews, and updating study records in the Clinical Trials Management System.
• Utilize 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 all aspects of study conduct, including:
  • Participant recruitment and accrual monitoring
  • Compliant regulatory management, including continuing reviews and amendments
  • Directing staff roles and responsibilities per Delegation of Authority
  • Protecting the safety and health of human subjects

Clinical Research Coordination (40%)

• Be primary contact and information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
• Engage with investigators and ensure research procedures comply with regulations, policies, and best practices.
• Screen and recruit potential research subjects.
• Work with investigators to ensure subject eligibility, facilitate subject enrollments, ensure the appropriate recording of adverse events, and timely acquisition of research tissue.
• Coordinate subject visits, ensure protocol requirements are met
• Ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.
• Facilitate the timely review and reporting of adverse reactions and severe adverse events
• Ensure compliance with requirements for registering subjects and study visits; facilitate compliant research billing of services
• Contribute to the production of research publications or presentations of research data

Research Operations and Process Improvement (10%)

• Serve as the primary CRP Education resource for the clinical research program and pediatric research teams, including implementation of new processes and standards
• Participate in work on internal business issues of moderate complexity, and recommend solutions and best practices
• Support development of standardized research practices and workflows
• Attend professional development and training sessions to ensure compliance with newest policies and procedures.
• Monitor trends and offer suggestions for improvements
• Assist with quality monitoring according to departmental procedures
• Support other special projects and program initiatives as directed

Staff Development and Supervision (20%)

• Direct supervision and mentoring of research support staff
• Interview, hire, and train new team members
• Perform performance evaluations and promote professional development
• Participate in the training of additional staff as requested

All required qualifications must be included in the application materials

Required Qualifications:

• BA/BS in a related field, and five years of relevant experience; or advanced degree with three years of relevant experience; or a combination of related education and experience to total nine years
• Experience preparing and managing IRB and other regulatory review submissions, including securing initial IRB approvals and required per-review approvals.
• Experience in Clinical Research

Preferred Qualifications:

• Expert knowledge of the federal regulations governing human subject research, including protections for vulnerable populations
• Computer proficiency, and ability to navigate multiple software applications.
• Electronic document management experience and strong skills with Adobe and Microsoft Word
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work independently, as a part of a team and with changing priorities
• Demonstrated ability to maintain deadlines and prioritize assignments
• Excellent written, verbal and interpersonal skills
• Masters-level degree in relevant field
• Project management experience
• Clinical Research Certification (CCRC or CCRP)

Essential Employees:

The successful candidate will be designated as an Essential Employee. Essential Employees are expected to report to campus during a University State of Emergency (reduced operations or campus closure) unless specifically directed by the Department not to report or if directed by civil emergency or medical authorities not to report for health and safety reasons. As an Essential Employee, you must report to campus even if the closure is less than 3 days.

At University of Minnesota Department of Pediatrics, our experts, care teams and researchers are illuminating cures that save young lives. Our ground-breaking treatments are improving the lives of children who are ill or injured, and are becoming the standards of care for children across the country and around the world.

The Pediatric Clinical Research Services program serves the University's research mission by providing comprehensive research support to faculty investigators conducting medical research in neonates, infants, children, adolescents, and young adults. We accomplish our mission by 1) developing competent professionals specialized in pediatric clinical research, 2) creating effective and efficient pathways for conducting compliant clinical research, and 3) fostering a participant-centric research culture.

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

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) 624-8647.

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.

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.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).

The University of Minnesota Medical School

Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.
The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations.

Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.