Urology Clinical Research Coordinator (Research Professional 1)

This position coordinates all aspects of clinical research studies in the Department of Urology, including both in-patient and out-patient clinical research under the direction of the Department of Urology Administrator and Principal Investigator.

Job Responsibilities:

• Study Participant Recruitment and Management - 50% of time
• Manage and coordinate research participant's participation, including patient recruitment, screening, consent, enrollment according to approved protocols;
• Coordinate participant study visits with guidance from clinical research staff;
• Schedule appropriate clinic appointments, procedures, testing, labs, and imaging studies per study protocol requirements;
• Prepare lab kits and provide investigational devices/drugs as necessary;
• Ensure appropriate billing designation for study visits by maintaining compliance in OnCore and EPIC systems;
• Collect appropriate study data directly (i.e., assess adverse events and protocol deviations, administer questionnaires, etc.) and from electronic medical records;
• Enter data into sponsor eCRF platforms and address queries as needed;
• Create and maintain participant binders with appropriate study CRFs and source documents;
• Coordinate monitor visits by sponsors and audits by Human Research Protection Program under guidance of clinical research staff (HRPP)

Study Start-Up - 25% of time

• Participate in site qualification visits, site initiation visits, and protocol training sessions with industry sponsors;
• Support investigators and clinical research staff in preparing and completing various regulatory and Institutional Review Board (IRB) applications in coordination with sponsoring companies;
• Assist in maintenance of study regulatory binders;
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training;
• Assists Principal Investigator to assure that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.

General Administrative- 15%

• Coordinates with Principal Investigator, department, Sponsored Projects Administration, and IRB to help ensure that clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures;
• Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office.
• Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors;
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations;
• Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office;
• Manage and coordinates all aspects of multiple Urologic clinical research studies.
  

Research Assistant to Faculty and Staff - 10% of time

• Miscellaneous administrative duties and assignments as requested

All required qualifications must be documented on application materials

Required Qualifications:

• BA/BS or combination of related education and work experience to equal 4 years;
• Experience working with healthcare data;
• Knowledge of research methodology;
• Possess excellent communication skills, verbal and written;
• Flexibility with work schedule to accommodate participant visits.

Preferred Qualifications:

• Previous University of Minnesota research experience;
• Previous experience coordinating clinical research;
• Experience with Epic;
• Strong written and oral communication skills;
• Previous experience working in Urology;
• Demonstrated ability to work independently and as part of a team.

To learn more about the Department of Urology, please visit med.umn.edu/urology.

• 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).