Position Summary: The Clinical Research Coordinator provides overall study management for research faculty on a variety of research studies to include; business and industry studies, investigator-initiated studies and NIH sponsored research. This position reports to the Department Administrator.
The research coordinator is a key member of the department’s research team and responsibility will manage research projects across the adult ophthalmology program and will provide some back up support of the pediatric program. Troubleshooting and independent problem solving skills will be important in this role. The position collaborates with other areas of the University to include Clinical Transitional Science Institute (CTSI) clinical research services, and the staff in the Ophthalmology clinic and MHealth Fairview research clinic in assuring that studies meet regulatory requirements, policies and procedures are completed according to the study protocol.
Major Duties/Job Description: 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 medicals records, etc.
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 to implement 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 study budget process including review of protocol amendments to ensure the budget supports the work required.
Work with department accountant 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 appointment, 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.
The University of Minnesota offers a comprehensive benefits package including:
Competitive wages, paid holidays, vacation and sick leave
Low cost medical, dental, and pharmacy plans
Health care and dependent daycare flexible spending accounts
Excellent retirement plans with employer match
Disability and employer paid life insurance
Wellbeing program with reduced insurance premiums
Tuition reimbursement opportunities covering 75%-100% of eligible tuition
All required qualifications must be documented on application materials.
Required Qualification 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. 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 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 University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.