About the Job

The Department of Urology is seeking a Co-Clinical Research Manager 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 Co-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 Co-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
Co-Research Manager of Clinical Trial Team- 30% 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 Participant Recruitment and Management - 40% of time
• Evaluate and assign participant recruitment efforts.
• Lead consenting and enroll appropriate participants with regard to the established protocols.
• Manage coordination of participant study visits.
• Schedule appropriate clinic appointments, procedures, testing, labs, and imaging studies per study protocol requirements.
• Manage appropriate billing designation for the study visits.
• 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.

Study Start-up 30%
• 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.

This position is performed in a hybrid work environment, with a minimum of three days per week on campus.

Qualifications

All required qualifications must be included in the application materials

Required Qualifications:
• Bachelor's degree in a life science, healthcare, or related field.
• 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 about the Department of Urology, please visit https://med.umn.edu/urology

About the Medical School

• 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.

About the Job

The Department of Urology is seeking a Co-Clinical Research Manager 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 Co-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 Co-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
Co-Research Manager of Clinical Trial Team- 30% 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 Participant Recruitment and Management - 40% of time
• Evaluate and assign participant recruitment efforts.
• Lead consenting and enroll appropriate participants with regard to the established protocols.
• Manage coordination of participant study visits.
• Schedule appropriate clinic appointments, procedures, testing, labs, and imaging studies per study protocol requirements.
• Manage appropriate billing designation for the study visits.
• 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.

Study Start-up 30%
• 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.

This position is performed in a hybrid work environment, with a minimum of three days per week on campus.

Qualifications

All required qualifications must be included in the application materials

Required Qualifications:
• Bachelor's degree in a life science, healthcare, or related field.
• 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 about the Department of Urology, please visit https://med.umn.edu/urology

About the Medical School

• 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.