60% - Provide Administrative Support to Initiate Clinical Trials
Internal approvals, as required, by individual protocols: IRB, Caner Protocol Review Committee (CPRC) for oncology-related protocols, scientific review, Radiation Review Committee, Department of Medicine.
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.
30% - Perform Study Functions, As Defined by Established Protocols
Ensure protocol compliance
Facilitate subject recruitment and screening, obtain subject consent, 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 with PI and to the study team all relevant medical patient information to manage study subjects in a safe and responsive manner.
Inform PI and clinical caretakers of adverse events and report Serious Adverse Events to protocol sponsors.
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.
Manage clinical trials supplies.
Facilitate closure of completed studies, including safe storage of study documentation.
5% - Promote Infectious Disease Study Protocols
Establish and maintain collaborative relationships with Investigational Pharmacy, BMT Patient Services, nursing, medical, laboratory and microbiology staff.
Act as liaison with other health care personnel, providing information about current study protocols and assistance with patient enrollment.
5% - Other Duties As Assigned
Maintain a good working relationship with the FDA Clinical Research Regulations and Good Clinical Practice (GCP) standards for Research.
Other duties as assigned
REQUIRED QUALIFICATIONS (Must be documented on application materials):
BA/BS in biological or health care-related field with at least 2 years of experience or a combination of related education and work experience to equal 6 years
Basic computer skills to include word processing and Excel
Willingness to assist in collection of body fluids (stool, urine, throat cultures, skin cultures) which does not include blood drawing but does include blood sample handling
Ability to prove non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza
Demonstrated strong problem-solving skills, strong patient relation skills, and ability to work independently
Current license to practice as a registered nurse
Certification by ACRP or SOCRA as a Clinical Research Coordinator
Previous experience with handling patient databases and electronic medical records
Demonstrated working knowledge of Federal Regulations, IRB/HIPAA guidelines, and good clinical practice guidelines
Internal Number: 330362
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.