Clinical Research Manager- Department of Urology

• The Department of Urology is seeking a Clinical Research Manager (Research Professional 4- Clinical Research) to manage its research portfolio. This position will work in partnership with Department leadership to develop and implement strategy aimed at continued research growth. The Clinical Research Manager for the Department of Urology will provide strategic leadership and oversight of the day-to-day operations related to the conduct of all clinical research for the Department of Urology research portfolio. The Manager will partner with the Department of Urology Principal Investigators (PIs), administration, and other faculty and staff to ensure that research requirements are being met and departmental research needs are addressed. This individual will lead PIs and staff through all aspects of study conduct, including grant submissions, start-up procedures (regulatory, budget, etc.), implementation, ongoing conduct and trial management, and close-out.

Job Responsibilities

• Study Participant Recruitment and Management - 40% of time
  • Evaluate and assign participant recruitment efforts to clinical trial coordinators.
  • Lead consenting and enroll appropriate participants with regard to the established protocols.
  • Manage coordination of participant study visits with the clinical trial team.
  • Schedule appropriate clinic appointments, procedures, testing, labs, and imaging studies per study protocol requirements.
  • Manage appropriate billing designation for the study visits by clinical trial coordinators.
  • Manage study data.
  • Collect appropriate study data directly (i.e., assess adverse events and protocol deviations, administer questionnaires, etc.) and from electronic medical records.
  • Enter data into eCRF platforms and address queries as needed.
  • Coordinate and oversee monitor visits by sponsors and audits by HRPP.
• Research Manager of Clinical Trial Team- 35% of time
  • Supervise research coordinators who are providing effort on business and industry grants. Assign staff to PIs who will provide daily work instruction on research projects.
  • Recommend the hiring of new staff and ensure proper orientation and training are provided.
  • Write and update job descriptions; delegate duties; conduct performance appraisals, and monitor progress of mutually agreed upon goals.
  • Ensure professional development of staff to ensure good clinical practice.
• Study Start-up 25%
  • Participate in site qualification visits and protocol training sessions with industry sponsors.
  • Prepare and complete Institutional Review Board (IRB) applications in coordination with sponsoring companies and investigators.
  • Facilitate appropriate ancillary review processes.
  • Serve as a liaison/advisor between investigators, sponsors, and regulatory committees.
  • Ensure compliance throughout the duration of the study.
  • Regulatory document maintenance.
  • Negotiate budgets with sponsoring companies.
  • Create protocol calendars in OnCore.

All required qualifications must be listed on resume.

Required Qualifications:

• Bachelor's degree in a life science, healthcare, or related field, plus at least five years of hands-on experience in clinical trial management from study startup through closure OR a combination of education and relevant work experience to equal at least nine years
• Knowledge of research methodology.
• A thorough understanding of global regulatory requirements and guidelines, such as ICH-GCP.
• Excellent written and verbal communication skills are necessary for collaborating with multidisciplinary teams and stakeholders.

Preferred Qualifications:

• Master's degree or Certified Clinical Research Professional (CCRP).
• Experience in supervising and mentoring clinical research teams.
• Demonstrate ability to work independently and as a part of a team.

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

Pay Range: $35.34- $38.46 an hour ($73,500- $80,000 annually), depending on education/qualifications/experience

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).