This is a job for a research professional 3. This role will serve as supervising capacity over employees and will be responsible for coordination and supervision of these employees. In addition, this role will be the lead study coordinator on more difficult/more complex studies, such as the Investigator-initiated, multicenter NIH-sponsored cytomegalovirus dried blood spot study.
40% - Research-Based Activities • Ensure protocol compliance with high complexity studies that are primarily assigned to the Research Professional 3 Coordinator. • Facilitate subject recruitment and screening, obtaining subject consent when so delegated by the Principal Investigator or sub-Investigator, monitor compliance of study subjects to protocol, coordinate study visits and obtain biological samples required by the protocols. • Timely data entry of all study subject data into case report forms and/or electronic databases. • Communicate and collaborate with study sponsors, and Investigational Review Board. • Assist study monitors with the site initiation visits, monitoring visits, and close out visits. • Maintain an accurate hourly account of time spent on each study in the appropriate tracking system. • Maintain patient confidentiality and compliance with HIPAA regulations. • Facilitate closure of completed studies, including safe storage of study documentation • Act as a liaison with other health care personnel, providing information about current study protocols and assistance with patient enrollment. • Establish and maintain collaborative relationships with Investigational Pharmacy, transplant patient services, nursing, medical, laboratory, and microbiology staff.
30% - Supervisory and Operational Work • Assist with selecting research team employee candidates for interview, interviewing, and reference checks. • Onboard and train new employees. • Delegating, assigning, and directing work (i.e., evaluating workload) of Research Professional 2 employees. • Work with the division’s Research Professional 4 employee to make sure that budgetary & contract aspects of studies being delegated to the Research Professional 2 employees are complete and ready for execution, prior to or concurrent with, delegation, as needed. • Be available to assist Research Professional 2 employees to prepare studies for execution and run these studies (labs, pharmacy, clinic study appointments). • Ensure protocol compliance with studies that are primarily assigned to the Research Professional 2 employees (recruitment and screening, study visits, biological samples as required, data entry of all study subject data into case report forms and/or electronic databases). • Order and maintain supplies while keeping budget records. Ensure that all items listed under Research-Based Activities (above), for studies that are assigned to the Research Professional 2 employees, are indeed being performed within GPC (Good Clinical Practice) guidelines.
20% - Administrative Support to Clinical Trials within Division • Assist with budget development and negotiation. Facilitate SPA contract negotiations through the established process. Establish utilization of University of MN Medical Center, Fairview, Fairview and MHealth resources. • Establish and maintain study binders with regulatory documentation. Update IRB and CPRC with protocol, informed consent, and regulatory documentation changes, as needed, based on amendments or other submitted documents. • Assist as needed with internal approvals, as required by individual protocols: IRB, Cancer Protocol Review Committee (CPRC) for oncology-related protocols, scientific review, Radiation Review Committee, Department of Medicine. • Maintain up-to-date knowledge of current compliance and regulatory compliance.
10% - Other Duties as Assigned - Assist other PIs within the division with research needs, as needed and as directed - Promote infectious disease study protocols - Other projects
All required qualifications must be documented on application materials.
Required Qualifications BA/BS plus at least 4 years of experience or advanced degree plus 2 years of experience or a combination of related education and work experience to equal eight years Strong communication skills, including ability to quickly assess, identify and resolve problems Innovative thinking and demonstrated prior collaboration among stakeholders Ability to troubleshoot and assist other team members as needed, including identification and implementation of process improvements Proven experience with confidential, HIPAA, and compliance regulatory requirements
Preferred Qualifications Previous experience with staff supervision (i.e. hiring, training and onboarding, etc.) Knowledge of maintaining adequate staffing for a multi-trial center Demonstrated experience managing multiple schedules and competing deadlines in a fast paced environment Previous experience assisting a PI with management and maintenance of trials Strong ability to learn, interpret and apply new systems quickly, such as electronic systems specific to a study which collects, stores and/or processes clinical samples Experience managing budgets and contracts Overesee resource allocation and deliverables
Internal Number: 335454
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.