Clinical Research Coordinator C

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Clinical Research Coordinator C

Clinical Research Coordinator C

This position will be a resource for best practices of managing major clinical trials. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, and sponsor. They will be a resource to other members of the team and will oversee the implementation of new clinical trials.

Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB are completed in a timely manner.

• Provide assistance to investigators with ocular examination, coordination of clinical trials, including recruiting new patients, maintaining high retention levels, interviewing participants, gathering medical data, coordinating visits with interdepartmental units ( retina /neurology ), PI/Photographers and laboratory personnel, completing records expeditiously.
• Interact with governmental regulatory agencies regarding human subject research, completing regulatory submissions to the IRB and monitoring compliance with all institutional regulatory guidelines.
• Maintain patient department research shared drive/BOX regarding study, documentation, enrollment logs and visit summaries.
• Complete study abstract for inter-departmental research departments requiring ophthalmology services, determine facilities/equipment are available to complete required visits per the protocol required findings, distribute abstract to requesting department/ophthalmologist/research team, confirm ICF includes required wording for required ophthalmology exam and testing, schedule appointments including emergency visits as required, track patient visits/procedures, follow-up on SAE and AE findings with requesting department, submit orders for protocol required testing, submit visit/procedure tracking documentation to department BA on a monthly basis, work with outside departments on the development of EPIC Smart Set to document exam and protocol requirements, work with ophthalmologist to confirm all required testing is performed and patient meets ocular inclusion/exclusion per study protocol.
• Collaborate with other investigators internally and at inter-departments and institutions.
• Perform ophthalmic testing and exams for non-COT certified coordinators.
• Train CRC on performing ophthalmic testing procedures.
• Act as resource for clinic staff and investigators for problem resolution.
• The ability to perform all ophthalmic diagnostic testing per protocol, including protocol refractions, protocol specific visual field testing ophthalmic imaging, and experimental device testing on clinical research patients seen within the department of Ophthalmology.
• Assist ophthalmologist with experimental ocular procedures performed in short procedure unit or exam room.
• Review, organization, and upkeep of all current Ophthalmic Exam and imaging protocols providing clear communication of these requirements to participating clinical staff, and physicians.
• Assist with full diagnostic research certifications of both equipment and performance for all ophthalmic studies requiring certification to perform diagnostic testing.
• Serving as liaison between the equipment vendors the use of software to transmit images/results to reading center), reading centers, participating clinical staff, and clinical research investigators.
• Traveling to PCAM/ Scheie…