Clinical Research Coordinator - IDIM

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:

80%- Study Functions for Clinical Trials

-Ensure protocol compliance with all aspects of the clinical trials ongoing by the clinical investigators and PI.
-Facilitate subject recruitment and screening, coordinate study visits, monitor compliance of study subjects to protocol, and obtain biological samples required by the protocols.
-Obtain subject consent or reconsent when applicable.
-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 patient confidentiality and compliance with HIPAA regulations.
-Manage clinical trials supplies.
-Facilitate closure of completed studies, including safe storage of study documentation.

10%- Administrative Support for Clinical Trials

-Facilitate 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.
-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.

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 all application materials)

- Bachelor's Degree with 2 years of experience or a combination of education and work experience to equal 6 years
- Proficient computer experience to include Microsoft Word and Excel or similar software
- 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.
- Able to provide proof of non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza

Preferred Qualifications:
- Bachelor's Degree in biological or health care-related field.
- Previous experience working with patient databases and electronic medical records
- 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.
- Certified by ACRP or SOCRA as a Clinical Research Coordinator
- Demonstrated working knowledge of Federal Regulations, IRB/HIPAA guidelines, and good clinical practice guidelines.

Pay Range: $21.38-$36.83, dependent on experience and education.

Time Appointment Category: 75%-100% Appointment (If job description above does not specify appointment or expected weekly hours, assume a 100% appointment.)

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University 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 Regents Tuition Benefit Program
• 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) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

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.

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

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).