Clinical Research Operations Manager

Clinical Research Operations Manager

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.

Qualifications

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.