Clinical Research Coordinator

position Summary:
The Clinical Research Coordinator (Research Professional 3) provides comprehensive, independent management of clinical research projects within the Department of Ophthalmology and Visual Neurosciences. This role oversees studies across adult and pediatric programs, serving as the primary liaison between investigators, sponsors, regulatory bodies, and clinical teams.
The position requires advanced knowledge of clinical research operations, including study start-up, regulatory management, subject coordination, data integrity, and fiscal oversight. The coordinator ensures compliance with institutional, federal, and sponsor regulations while mentoring junior staff and supporting departmental research growth.
Major Responsibilities:
Research Study Management (55%):

• Independently coordinate all aspects of assigned studies, including start-up, subject recruitment, informed consent, visit scheduling, and data management.
• Serve as the primary point of contact for sponsors, monitors, and clinical partners.
• Lead site initiation, monitoring, and closeout visits.
• Ensure accurate source documentation, data entry, and timely reporting of adverse events.
• Manage investigational product accountability and maintain audit-ready records.
• Coordinate specimen management, including preparation, shipping, and inventory tracking.
• Oversee proper documentation of clinical procedures and ensure patient safety and data accuracy.

Regulatory Oversight (20%):

• Prepare and submit IRB applications, renewals, modifications, and adverse event reports.
• Ensure compliance with FDA, NIH, and institutional regulations.
• Maintain complete and current regulatory binders for all assigned studies.
• Coordinate audit preparation and response with CTSI and institutional offices.
• Provide regulatory guidance and serve as a resource for research staff to ensure compliance.

Fiscal Management (15%):

• Develop study budgets in collaboration with departmental finance staff.
• Track sponsor payments and reconcile study accounts.
• Ensure accurate billing and documentation of research-related services.
• Review protocol amendments to ensure budget updates align with study requirements.
• Support pre- and post-award financial processes as needed.

Training and Mentorship (5%):

• Provide onboarding and ongoing training to new research staff, residents, and fellows.
• Serve as a resource for regulatory and operational best practices across the department.
• Mentor junior coordinators in study management and professional development.
• Participate in departmental and institutional professional development activities, including CTSI seminars and certification opportunities.

Administrative & Quality Improvement (5%):

• Attend departmental research meetings and CTSI seminars.
• Support departmental research process improvements and policy development.
• Contribute to manuscript preparation, presentations, and research dissemination efforts.
• Collaborate with clinical and administrative staff to improve workflow efficiency and study outcomes.

Supervision Received and Exercised:
Works under minimal supervision, exercising independent judgment within established guidelines. May provide guidance, training, and oversight to Research Professionals 1-2, students, or fellows involved in research activities.

All required qualifications must be documented on Application materials.

Required Qualifications:

• Bachelor’s degree and 4 years of clinical or research experience, or an equivalent combination of education and experience totaling 8 years.
• Demonstrated expertise in Good Clinical Practice (GCP), FDA Code of Federal Regulations, and IRB processes.
• Proficiency in research management systems (e.g., OnCore, Epic, REDCap).
• Strong analytical, communication, and problem-solving skills with the ability to work independently and manage complex projects.
• Ability to manage multiple priorities and work collaboratively across clinical and research teams.
• Detail-oriented with exceptional organizational and time management skills.
• Possess excellent communication (written and verbal) and interpersonal skills

Preferred Qualifications:

• Certified Clinical Research Coordinator (CCRC or equivalent).
• Experience leading or coordinating multi-site, investigator-initiated, or FDA-regulated (IND/IDE) trials.
• Familiarity with ophthalmology and/or vision science research.
  • Previous experience with Ophthalmology specialty a plus.
• Experience mentoring or training junior coordinators or research staff.
• Budget and billing management experience.
• Ability to work in a matrixed environment

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: $30.89 to $35.50 per hour, we anticipate most offers will be around the midpoint of this range, depending on education and experience.

Time Appointment: 100% Appointment

Position Type: Civil-Service

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, pharmacy and disability plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• 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).