Clinical Research Operations Manager

Working Title: Clinical Research Operations Manager

Job Code Title: Research Professional 5 - Clinical Research Project Management

Job Code: 9791CP

Position Summary:

The Ophthalmology Clinical Research Manager is a working manager responsible for the strategic design and operational execution of the department's clinical research portfolio, including National Institutes of Health (NIH), business & industry, and investigator-initiated trials. This role is tasked with transitioning the department from an ad-hoc environment to a structured, high-performing research unit. The incumbent will establish departmental Standard Operating Procedures (SOPs), set clear expectations for Principal Investigator (PI) engagement, and serve as the primary clinical backup for all research studies.

Please Note: This is a 100% in-person position located on the University of Minnesota Twin Cities campus. The successful candidate will be required to work on-site full-time, five days per week. Remote or hybrid work is not currently an option for this role. While in-person requirements may be adjusted in the future based on evolving departmental needs, a consistent on-site presence is required at this time.

Key Responsibilities:

1. Process Architecture & PI Management (45%)

• Workflow Design: Develop and implement the first formal SOPs and "onboarding kits" for the department to eliminate "re-work" and procedural errors.
• Faculty Stewardship: Consult with PIs on protocol feasibility and resource needs, while establishing clear boundaries and accountability for PI oversight.
• Infrastructure Building: Create and manage the Research Services Portal or similar intake process to manage proposals and recruitment requests.
• System Integration: Navigate and master University systems (ETHOS, OnCore, REDCap) to create a streamlined departmental workflow.

2. Clinical Research Facilitation (Working Manager) (30%)

• Lead Coordination: Serve as the primary "backup" for staff; must be proficient in screening, consenting, and enrolling subjects to ensure study continuity.
• Protocol Oversight: Ensure all protocols are followed and study activities are documented correctly to meet the high quality-control standards of department leadership.
• Regulatory Management: Lead and guide faculty with Institutional Review Board (IRB) materials and regulatory submissions, ensuring the department is "audit-ready" at all times.

3. Team Leadership & Professional Development (20%)

• Supervision: Manage the hiring, training, and performance evaluation of the clinical research coordinators.
• Conflict Resolution: Partner with the Department Leadership and Human Resources to resolve complex employee relations and performance issues.
• Training: Provide direction to staff for new systems and processes as they are built.

4. Administrative & Writing Support (5%)

• Dissemination: Support faculty with the preparation of abstracts, manuscripts, and reports.

All required qualifications must be documented on application materials.

Required Qualifications:

• BA/BS in a related field with at least 6 years of clinical research experience, OR an advanced degree with at least 4 years of experience.
• Demonstrated experience managing or leading research teams and projects.
• Deep knowledge of Good Clinical Practice (GCP) and federal research regulations.
• Exceptional organizational, problem-solving, and communication skills.

Preferred Qualifications:

• University Systems: Experience with OnCore, ETHOS, and REDCap.
• Certification: Certified Clinical Research Coordinator (CCRC).
• Specialized Experience: Experience in Ophthalmology research or managing NIH-funded and industry trials.
• Strategic Building: Proven track record of creating research infrastructure or implementing process improvements in a clinical setting.

The Department of Ophthalmology and Visual Neurosciences and its success is built upon the innovation and drive of every member of our team, from faculty to administrators to technicians. Put simply, all of us are driven to provide the best eye care for our patients, discover new treatments, and educate the next generation of eye care professionals.

For more information please visit our website at https://med.umn.edu/Ophthalmology.

Pay Range: $98,092.80 - $110,000 annually and we anticipate most offers will be around the midpoint of this range, depending on education and experience.

Time Appointment: 100% Appointment

Position Type: P&A 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).