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.
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.
