Clinical Research Coordinator

Job description:

The Clinical Research Coordinator works closely with pharmaceutical companies, assisting principal investigators in recruiting and management research studies directly affecting the eyecare industry.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Interpret, comprehend, and conduct clinical research procedures while following all protocols.
• Oversee all aspects of patients involved in clinical trials. Ensure procedures are completed properly, while taking guidance from sponsors. Follow up and keep track of patients care at all times.
• Pre-screen detailed chart review of potential patient records. Call referring physicians to discuss patients, follow up with patients to discuss details of the trial and take proper documentation.
• Manage and ensure completion of all study start-up documents for proper documentation and compliance.
• Discuss and review in detail the informed consent with patients and their family members to ascertain proper informed consent per GCP guidelines.
• Provide direction to staff and providers relative to the daily activities and tasks associated with conducting each clinical research.
• Train staff as necessary to ensure compliance and protocol for each trial.
• Prepare and ensure accurate IRB submissions, including additional review, safety, and close-out reports.
• Coordinate site visits with Sponsors to ensure professional representation of Azul Vision and positive sponsor experience.
• Oversee completion of delegation logs and delegation training for all clinical research personnel.
• Maintain all regulatory binders in accordance with Sponsors specifications and general industry standards.
• Create, implement, and maintain all clinical research related to SOP’s.
• Report and follow-up on all adverse events.
• Oversee recruitment, management, and follow-up of patients involved in clinical trials.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Perform photography including OCT/ Color Fundus/ Fluorescein angiography / Visual Field / Specular Microscope.
• Accurately performs Snellen VA or manual refraction/ tonometry.
• Responsible for performing ECGs and vital signs.
• Perform ophthalmic and research technician duties.
• Other duties as assigned.