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    Minneapolis, United States University of Minnesota Physicians Full time

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Clinical Research Coordinator 2

2 months ago


Minneapolis, United States University of Minnesota Twin Cities Full time

The Department of Medicine is hiring a Clinical Research Coordinator (CRC/ RP3) to support clinical research projects conducted by the departmentâs Research Operations and Resources (ROAR) Team. The Department of Medicine is one of the top research departments in the United States and represents the largest research faculty group at the University of Minnesota, comprising 11 divisions. The MED ROAR Team supports a high volume of varied research projects across the divisions. This position will be working with Dr. Susan Kline, clinical investigator in the Department of Medicine, Division of Infectious Diseases and International Medicine.

20%- Administrative Support for Clinical Trials

â¢Facilitate internal approvals, as required, by individual protocols: for the University of MN Institutional Review Board (IRB) â¢Assist with budget development. Facilitate SPA contract negotiations through the established process. Establish utilization of University of MN Medical Center, Fairview, Fairview and MHealth resources. â¢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.

70%- Study Functions

â¢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. â¢Timely data entry of all study subject data into case report forms and/or electronic databases. â¢Assist in collection of body fluids (stool or perianal, urine, throat and nasal cultures, skin swab cultures), as required by study protocols. â¢Ensure protocol compliance. â¢Communicate with PI and to the study team all relevant medical patient information to manage study subjects in a safe and responsive manner. â¢Inform PI and clinical caretakers of adverse events and report Serious Adverse Events to protocol sponsors. â¢Communicate and collaborate with study sponsors, and IRB. â¢Maintain an accurate hourly account of time spent on each study in the appropriate tracking system. â¢Maintain patient confidentiality and compliance with HIPAA regulations. â¢Manage clinical trials supplies. â¢Facilitate closure of completed studies, including safe storage of study documentation.

5%- Communications

â¢Establish and maintain collaborative relationships with Investigational Pharmacy, nursing, medical, laboratory and microbiology staff. â¢Act as liaison with other health care personnel, providing information about current study protocols and assistance with patient enrollment. â¢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 all application materials)

â¢Bachelorâs Degree in biological or health care-related field with 2 years of experience or a combination of education and work experience to equal 6 years â¢Proficient computer experience to include Microsoft Word and Excel or similar software â¢Experience working with patient databases and medical records â¢Demonstrated strong problem-solving skills, strong patient relation skills, and ability to work independently â¢Willingness to assist in collection of body fluids (stool, urine, throat cultures, skin cultures), as required by study protocols. â¢Proof of non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza

Preferred Qualifications:

â¢Previous experience working in a clinical medical or nursing facility such as a hospital, clinic or nursing home. â¢Previous clinical research experience, including data collection from study subjects and completing case report forms. â¢Experience initiating clinical trials, including acquiring internal approvals, documentation and regulation management. Working knowledge of Federal Regulations, IRB/HIPAA guidelines, and good clinical practice guidelines.

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