Clinical Research Manager- Department of Urology

Apply for Job Job ID370230 LocationTwin Cities Job FamilyResearch Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8354CR Employee ClassCivil Service Add to Favorite Jobs Email this Job About the Job 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. Qualifications 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. About the Department To learn more a out the Department of Urology, please visit: med.umn.edu/urology. Pay and Benefits 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 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

Created: 2025-11-01