Research - Laboratory/Non-Laboratory, Staff/Administrative
Dr. Jo-Anne Young, clinical investigator in the Department of Medicine, Division of Infectious Diseases, is seeking a study coordinator to assist with the preparation and conduction of clinical research.
Job Duties & Responsibilities 60% - Administrative Support for Clinical Trails -Facilitate 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% - Study Functions -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% - Communications -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. - Maintain a good working relationship with the FDA Clinical Research Regulations and Good Clinical Practice (GCP) standards for Research.
5% - Other Duties as Assigned
Required Qualifications (must be documented on application materials) - Bachelor’s Degree in biological or health care-related field plus at least two years of experience, or a combination of education and work experience to equal at least 6 years. - Proficient computer experience to include Microsoft Word and Excel or similar software - Previous experience working with patient databases and electronic medical records - Demonstrated strong problem-solving skills, strong patient relation skills, and ability to work independently - Willingness to assist in collection of body fluids (stool, urine, throat cultures, skin cultures), as required by study protocols. This does not include blood drawing, but blood samples will be handled. - Proof of non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza
Preferred Qualifications - Graduate of an accredited school of nursing - Current license to practice as a registered nurse - Certified by ACRP or SOCRA as a Clinical Research Coordinator - Previous clinical research experience, including data collection from study subjects and completing case report forms. - Experience initiating clinical trials, including acquiring internal approvals, budget negotiations, documentation and regulation management. - Demonstrated working knowledge of Federal Regulations, IRB/HIPAA guidelines, and good clinical practice guidelines.
Internal Number: 336094
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.