Clinical Research Coordinator​/Certified Ophthalmic Technician

Position Summary

Position Summary:

The Clinical Research Coordinator / Certified Ophthalmic Technician 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 Translational 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 (40%): 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.

• Specialized Clinical & Diagnostic Research Duties (40% Effort): This position functions as the lead Research Ophthalmic Technician (COT) for all assigned clinical studies, independently performing non-physician patient care, clinical assessments, and advanced diagnostic testing as required by the protocol. This requires advanced knowledge of ophthalmic disease and diagnostic instrumentation.
• Advanced Diagnostic Imaging & Testing:
  Independently perform, calibrate, and quality-check a variety of complex ophthalmic diagnostic exams, including but not limited to:
  Optical Coherence Tomography (OCT), B-scans, corneal topography, microperimetry, full-field stimulus testing (FST), electroretinography (ERG), and specialized visual field testing.
• Ophthalmic Patient Assessment:
  Conduct detailed patient workups, including obtaining a thorough medical and ocular history, performing manifest refraction, measuring intraocular pressure (Goldmann or Tonopen), assessing visual acuity, pupillary response, and ocular motility.
• Clinical Support:
  Instill eye drops for dilation or other protocol-required purposes and assist the Principal Investigator (PI) with in-clinic minor surgical procedures, injections, or laser treatments.
• Technical Data Management:
  Be solely responsible for the generation, quality control, and interpretation of all clinical diagnostic source data used for Case Report Form (CRF) submission and sponsor monitoring.

• Research Project Management Duties (15%): 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…