Clinical Research Coordinator

About the role

The Clinical Research Coordinator (Research Professional 3) provides comprehensive, high-level study management on a variety of research studies 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. This position is a key member of the department’s research team and requires significant troubleshooting and independent problem-solving skills.

Responsibilities

• Research Study Coordination (45%)
  • Independently lead and oversee subject screening, recruitment, eligibility verification, and enrollment.
  • Facilitate timely acquisition of research samples and manage specimen logistics (preparing kits, shipments, inventory tracking).
  • Delegate and ensure complete and accurate study data collection through patient interactions, surveys, and electronic medical records.
  • Perform ophthalmic technical procedures (e.g., visual acuity, tonometry, perimetry, imaging) as required by study protocols and train team members on these procedures.
  • Maintain subject research charts in adherence to Good Clinical Practice (GCP) and sponsor requirements.
  • Enter study data into OnCore clinical trials management system and sponsor platforms, ensuring quality control for data entered by team members.
  • Collaborate with Investigators to review and report adverse reactions and severe adverse events.
  • Ensure accurate patient billing by appropriately documenting study subject visits.
  • Serve as the primary point of contact for sponsors and contractors during site initiation visits, monitoring visits, program audits, and closeout visits.
  • Implement accurate device and drug accountability processes according to sponsor and regulatory requirements.
  • Coordinate study needs with the Eye Clinic, Clinical Research Unit, and Investigational Drug Services (IDS) to execute study visits per protocol.
  • Provide guidance to clinic staff on ophthalmic technical procedures as required by study protocols.
  • Maintain accurate subject reimbursement, track sponsor payments, and reconcile study accounts.
  • Ensure accurate billing and documentation of research-related services.
  • Review protocol amendments to align budget updates with study requirements.
  • Support pre- and post-award financial processes as needed.
• Data Management (30%)
  • Serve as the primary contact for collecting and completing required study documentation.
  • Develop and maintain study documentation to ensure audit-proof compliance.
  • Abstract data from medical records to ensure accurate and complete documentation.
  • Manage electronic data capture systems, including data entry, query resolution, and meeting data lock deadlines.
  • Demonstrate proficiency with adverse event grading, medical terminology, critical lab values, and disease-specific diagnostic criteria.
  • Oversee proper documentation of clinical procedures to ensure patient safety and data integrity.
• Inter-departmental Coordination (5%)
  • Coordinate research study procedures for other departments requiring ophthalmology services per protocol.
• Regulatory (20%)
  • Identify, review, and report adverse events, protocol deviations, or other unanticipated problems.
  • Independently contribute to study start-up activities, such as site initiation visits and staff training.
  • Prepare and submit regulatory documentation, including IRB applications, revisions, safety reports, adverse events, modifications, and yearly renewals.
  • Create and maintain source documents and 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.
• Other Duties
  • Attend departmental research meetings and CTSI seminars.
  • Support departmental research process improvements and policy development.
  • Collaborate with clinical and administrative staff to improve workflow efficiency and study outcomes.
  • Serve as a resource for regulatory and operational best practices across the department.
  • Mentor junior coordinators in study management and professional development.
  • Assist the clinical research manager in developing study budgets.

Requirements

• Bachelor’s degree and 4 years of clinical or research experience, or a combination of related education and work experience totaling 8 years.
• Relevant and direct experience in clinical research, including data management and adherence to clinical research Standard Operating Procedures, Code of Federal Regulations for clinical trials, and Good Clinical Practice guidelines.
• Computer proficiency and ability to navigate multiple software applications.
• Detail-oriented with exceptional organizational, planning, and problem-solving skills.
• Ability to work in a complex environment and maintain professionalism when interacting with research participants who may have significant medical concerns.
• Strong verbal and written communication skills in English.
• Ability to work independently, as part of a team, and with changing priorities.

Qualifications

• Preferred Qualifications
  • Previous experience in a lead, supervisory, or mentorship role in clinical research within an academic setting.
  • Certification (COA/COT) or relevant experience as an Ophthalmic Technician and/or previous experience in Ophthalmology.
  • Experience abstracting clinical data and familiarity with medical terminology in both adult and pediatric studies.
  • Clinical Research Coordinator certification (CCRC or CCRA).
  • Experience with electronic health systems, preferably EPIC, OnCore, and clinical trial data collection platforms.

About the Department

The Department of Ophthalmology and Visual Neurosciences is built upon the innovation and drive of every team member, from faculty to administrators to technicians. The department is dedicated to providing the best eye care, discovering new treatments, and educating the next generation of eye care professionals. For more information, visit the department’s website.

Pay

Pay Range: $32.28–$37.00 per hour. Most offers are anticipated to be around the midpoint of this range, depending on education and experience.

Schedule

100% appointment (40 hours per week), civil-service position.

Benefits

• 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.