Clinical Research Coordinator

Position Summary:

The Clinical Research Coordinator (CRC) is a key member of the Department's research team, providing overall study management for faculty across a diverse portfolio of clinical trials, including NIH-sponsored, investigator-initiated, and industry-sponsored research. The CRC primarily manages projects within the Adult Ophthalmology Program, offering backup support for the Pediatric Program. This role requires strong independent problem-solving and troubleshooting skills to ensure strict adherence to all study protocols, regulatory requirements, and policies. The Coordinator collaborates actively with University partners, including the Clinical Translational Science Institute (CTSI), Ophthalmology clinic staff, and the MHealth Fairview research clinic. This position reports to the Department Administrator.

Job Responsibilities:

Research Study Coordination (60%)

• Work closely with the Investigators in subject screening and recruitment, verifying subject eligibility, facilitating subject enrollments, and timely acquisition of research samples.
• Provide effective specimen management, including preparing kits, preparing shipments, tracking inventory, etc.
• Responsible for complete and accurate study data collection, through patient interactions, survey management, electronic medical records, etc.
• Perform ophthalmic technical procedures (e.g., visual acuity, tonometry, perimetry, imaging) as required by the study protocol, minimizing the need for outside clinical staff support.
• Create source documents for accurate data collection.
• Responsible for the maintenance of subject research charts in adherence to Good Clinical Practice and sponsor requirements.
• Implement a process to track subject visits and ensure protocol timelines are met.
• Enter all study and subject data into OnCore clinical trials management system and required sponsor platforms.
• Work with the Investigators to ensure the timely review and reporting of adverse reactions and severe adverse events.
• Entering all study subjects visits appropriately to make sure patient billing is accurate.
• Implement and maintain accurate subject Clincard payments.
• Lead and manage relationships with sponsors and contractors to conduct site initiation visits, monitoring visits, program audits, etc.
• Responsible for implementing accurate device and drug accountability processes according to sponsor and regulatory requirements.

Research Project Management Duties (30%)

• Responsible for research study start up process to include: Preparation of regulatory applications, consent and HIPAA forms and applicable documents to meet institution and sponsor requirements.
• Liaison between department and the University IRB staff and associated Ancillary Reviews to ensure applicable review are completed (Fairview, Hipco, CTSI, Scientific Review).
• Work with CTSI Regulatory Services to support Business and Industry protocols to include local and central IRB applications.
• Develop and manage a tracking system to ensure regulatory review submissions, modification and continuing review deadlines are met.
• Maintenance of regulatory binders (paper and electronic) and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time.
• Responsible for implementation of the research protocol in collaboration with the clinical teams to foster an environment of quality research participation within the context of exceptional clinical care.
• Oversee and responsible for the completion of the study budget process including review of protocol amendments to ensure the budget supports the work required.
• Work with the department accountant(s) to monitor incoming study payments.
• Maintain the Oncore system to ensure billing compliance and accurate documentation.
• Track clinical research projects across the department to include medical students, residents and fellows to ensure projects are tracked and in compliance with the IRB.

Coordinate Research Studies for the department (5%)

• Coordinate research studies for other departments who require ophthalmology services for eligibility.
• Work with patients to schedule appointments, be present for the exam, complete all required source documentation for primary Clinical Research Coordinator.
• Provide support and assistance to the clinical research team.

Misc. educational and department duties (5%)

• Attend bi-monthly CTSI Clinical Research Professional Development Seminars and other educational opportunities as appropriate.
• Support quality improvement initiatives.

All required qualifications must be documented on application materials.

Required Qualifications:

• Bachelors' degree and 4 years of clinical or research experience or a combination of related education and work experience to equal 8 years.
• Relevant and direct experience in clinical research to include data management and following clinical research Standard Operating Procedures, the Code of Federal Regulations for clinical trials and Good Clinical Practice guidelines.
• Demonstrated 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.
• Ability to work independently, as a part of a team and with changing priorities.
• Possess excellent communication (written and verbal) and interpersonal skills.

Preferred Qualifications:

• Certified Clinical Research Coordinator.
• Certification (COA/COT) or relevant experience as an Ophthalmic Technician.
• Previous experience with Ophthalmology specialty.
• Experience in both adult and pediatric studies.
• Relevant and direct experience with regulatory requirements including study monitoring, Institutional Review Board submissions, Investigation New Drug (IND) and/or Investigational Device (IDE) submissions.
• Experience with Epic or other electronic medical record system.

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: $32.31 - $36.00, with most offers expected to fall in the middle of this range.

Time Appointment: 100% Appointment (40 hours per week)

Position Type: Civil-Service 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, 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).