Research Professional 4-Clinical Research

University of Minnesota; Saint Paul (MN); Hybrid; USD 73,000 - 85,000; Full time

Benefits offered by this job

Hybrid work model

On-campus 3 days per week

Comprehensive benefits

Job summary

The University of Minnesota's Department of Urology is seeking a Co-Clinical Research Manager to lead its clinical research portfolio and ensure regulatory compliance. You will partner with PIs and staff to manage startup through close-out of studies, including budgeting, regulatory documents, and trial management.

This hybrid role requires a strong background in clinical research, effective communication, and the ability to lead multidisciplinary teams across on-campus and off-campus activities.

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

Responsibilities

• Supervise research coordinators who are providing effort on business and industry grants.
• Recommend the hiring of new staff and ensure proper orientation and training.
• 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.
• 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.

Skills

Clinical trial management

Regulatory compliance

Communication skills

Education

Bachelor's degree in life science, healthcare, or related field

Master's degree or CCRP (preferred)

Job description

Job Details

Job ID: 375900

Location: Twin Cities

Full/Part Time: Full-Time

Regular/Temporary: Regular

Job Code: 8354CR

Employee Class: Civil Service

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

• 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.
• The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations
• Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.

Pay and Benefits

Pay Range: $35.21- $40.63 an hour ($73,236- $84,510 annually); depending on education/qualifications/experience

Time Appointment: 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

While our salary ranges provide a framework, it is important to note that most of the time, the initial pay may not reach the maximum of the range. This approach ensures that compensation reflects the value and unique contributions of each candidate while maintaining equity within our organization. As part of our commitment to fair and equitable compensation, please be aware that the salary offered to incoming candidates will be based on their individual credentials and experience.

Diversity

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

Employment Requirements

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.

About University of Minnesota

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 Forbes as a Best Employer for Company Culture (2026), Best Employer for Women (2023, 2025, 2026), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence & Industry Awards recognition for employee appreciation and work-life flexibility.