Job ID360509 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P3 Employee ClassCivil Service About the Job Dr. Susan Kline, clinical investigator in the Department of Medicine, Division of Infectious Diseases, is seeking a clinical research coordinator to assist with the preparation and conduction of clinical research. 20%- Administrative Support for Clinical Trials *Facilitate internal approvals, as required, by individual protocols: for the University of MN Institutional Review Board (IRB) *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. *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. *Design and provide training concerning protocol and study procedures. 70%- Study Functions *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. *Collection of body fluids (stool or perianal, urine, throat and nasal cultures, skin swab cultures), as required by study protocols. *Ensure protocol compliance. *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 IRB. *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. *Independently ensures that all study subjects complete study visits in timely manner to meet study criteria. 5%- Communications *Establish and maintain collaborative relationships with Investigational Pharmacy, nursing, medical, laboratory and microbiology staff. *Able to independently complete complex problem solving during conduct of clinical trial. *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 Qualifications Required Qualifications: (Must be documented on all application materials) *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. *Proficient computer experience to include Microsoft Word and Excel or similar software. *Experience working with patient databases and 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. *Proof of non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza. *Excellent verbal, written and interpersonal communication skills. *Ability to work well with patients' and research participants' care teams in the clinic, peri-operative area and in the hospital. *Ability to work independently, as part of a team, guided by Principle Investigator. Preferred Qualifications: *Experience working with Epic. *Previous experience working in a clinical medical or nursing acility such as a hospital, clinic or nursing home. *Previous clinical research experience, including data collection from study subjects and completing case report forms. Experience with electronic case report form systems. *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. *Proficient in Good Clinical Practices (GCP) *Clinical Research certification or equivalent. About the Department Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery. The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations. Benefits Working at the University At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work. The University also offers a comprehensive benefits package that includes: Competitive wages, paid holidays, and generous time off Continuous learning opportunities through professional training and degree-seeking programs supported by the Low-cost medical, dental, and pharmacy plans Healthcare and dependent care flexible spending accounts University HSA contributions Disability and employer-paid life insurance Employee wellbeing program Excellent retirement plans with employer contribution Public Service Loan Forgiveness (PSLF) Financial counseling services Employee Assistance Program with eight sessions of counseling at no cost Please visit the for more information regarding benefits. How To Apply Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume. Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section. To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647. Diversity The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees... For full info follow application link. The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.