Job ID355942 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P4 Employee ClassCivil Service About the Job In close partnership with the senior program leadership, 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. 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 polic es 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 Qualifications All required qualifications must be documented on 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 Preferred Qualifications: Expert knowledge of the federal regulations governing human subject research, including protections for vulnerable populations Experience preparing and managing IRB and other regulatory review submissions, including securing initial IRB approvals and required per-review approvals. 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 Experience in Pediatric Clinical Research Clinical Research Certification (CCRC or CCRP) Project management experience About the Department 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 supports a variety of research projects and portfolios in the Department of Pediatrics. We serve 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. We especially strive to have our community better reflect the broad range of identities in our state, including race, ethnicity, gender identity, gender expression, sexual orientation, language, disability, age, national origin, religious practice, access to health services, and socioeconomic status. Our program seeks to foster an inclusive environment in which members from diverse backgrounds are encouraged to develop their skills of scientific... For full info follow application link. 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.