This Research Project Manager (PM) will serve as the primary contact in the Infectious Disease research unit and will be responsible for facilitating the research of clinical investigators, led by Dr. Jo-Anne Young. Initially, there will be an emphasis on professional management of a large portfolio of clinical trials for transplant patients coming from business and industry. There will be supervision of usually two study coordinators, and the size of the coordinator pool can vary based on the number of studies. The PM will work with investigators to oversee the management and timely completion of research studies, including working with team members representing other functions (e.g., site coordination, data management, biostatistics, etc.). The PM will be able to assist investigators at all steps of the clinical studies, including from the proposal phase through data entry to manuscript development.
Job Duties/Responsibilities 90% - Professional Manager and Research Coordinator The PM will serve as the overall professional manager and research coordinator for a large portfolio of Infectious Disease clinical trials. Most studies are clinical trials for transplant patients coming from business and industry. Most studies are identified by the investigators, and the PM assists with feasibility surveys, budgeting, regulatory documents, data entry, study closure, in other words, the entire study chain of events. There will be supervision (in conjunction with Dr. Jo-Anne Young or her designee(s)), of usually two advanced study coordinators, and the size of the coordinator pool can vary based on the number of studies. Specifically: • The PM will assist investigators by providing strategic and operational expertise to investigators relative to clinical trials, IRB submissions, grant applications, and other clinical and translational research processes. The PM should have a thorough knowledge of internal and external funding resources and requirements. • The PM must discern, based on the protocol, which University of Minnesota approvals are required to conduct the research study. Once discerned, the PM will be responsible for shepherding applications and correspondence through the processes until approvals are obtained. The PM exercises independent judgment throughout these approval processes. The most common internal applications required include: the Institutional Review Board (IRB), the CV Scientific Review Committee, the Institutional Biosafety Committee (IBC), and the All University Radiation Protection and Use Committee (AURPAC). • The PM will also be responsible for exercising discretion and independent judgment in formulating and negotiating budgets for research studies. Formulating and negotiating budgets includes collecting and analyzing information for personnel time, facility fees, procedure fees, operating room fees, hospitalization costs and the costs of supplies from outside vendors. Independent judgment in estimating personnel costs is required. Subcontracts for employees from Fairview and University of Minnesota Physicians may need to be prepared. Formulating and negotiating budgets also requires the PM to lead the discernment process of accurately separating tests and procedures that would be performed as part of standard care from those that will be done solely for research purposes. Budget negotiation responsibilities of the PM begin in making recommendations to and negotiating with the faculty principal investigator. After principal investigator approval, budget negotiation continues with representatives from the sponsoring company or agency. The PM is given the authority to and is responsible for formulating and negotiating a budget that will pay for all the costs of the research study. • Other responsibilities include auditing invoices from outside vendors to make certain they are within the amount quoted by the vendor and the amount budgeted; and anticipating or discovering any issues that have the potential to jeopardize performance of the clinical study and/or that require an amendment to the work scope, responsibilities, and budgets. • The PM advises pharmaceutical and medical device companies by identifying whether the University of Minnesota can conduct their proposed clinical studies. • Excellent verbal and written communication skills are mandatory. Effective communication with physicians, study coordinators, clinic and hospital staff, departmental accountants, University regulatory offices, and representatives from the sponsor is critical to the successful performance of PM duties. • The PM will also meet standards in the areas of cooperation/teamwork, maintenance of smooth and effective working relationships, dependability and commitment, initiative and independence of action, and planning, problem solving and decision-making.
5% - Trainer • The PM develops and participates in the training of research coordinators and other research staff on CFR, GCP, NIH rules and local requirements in the conduct of clinical research. The PM works with other offices and committees within the University of Minnesota, the University of Minnesota Medical Center-Fairview and University of Minnesota Physicians to facilitate change and to make recommendations for improving research compliance and processes. • The PM will assist in training office staff, junior investigators, new faculty, new fellows, and others, on research practices and policies at the University of Minnesota as assigned.
5% - Miscellaneous • Miscellaneous other duties as assigned.
Required Qualifications (Must be documented on application materials): • B.A. or B.S. degree with five years experience in a health, public health or biomedical discipline or a combination of related education and work experience to equal nine years. • Extensive experience with clinical and/or translational research processes. • Ability to work with investigators of all experience levels, senior level administrators, as well as technical staff. • Experience in the management of resources and research projects. • Experience working with diverse populations. • Strong organizational skills, including evidence of the ability to multi-task. • Willingness and ability to work with a variety of electronic platforms for data entry. • Advanced level skills in Microsoft Word and Microsoft Excel • Excellent verbal and written communication skills.
Preferred Qualifications • Advanced degree in health or biomedical discipline or public health. • Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA) certification or willingness to sit for such an examination when eligible. • Familiarity with academic medical centers, particularly the University of Minnesota system and processes
Internal Number: 333376
About University of Minnesota, Twin Cities
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.