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.

Requirements

• High School Diploma or GED required. Bachelor's degree preferred.
• A minimum of 2 years of experience in the clinical research industry
• Prior ophthalmic technician experience is highly desired.
• Through knowledge of eye anatomy, disease, symptoms, and ocular medications.

Skills / Abilities

• Exceptional organizational skills - will be expected to balance multiple tasks, respond promptly to emails, and re-prioritize tasks based on last-minute deadlines.
• Ability to interact with supervisory staff, physicians, peers, external customers, and patients positively, energetically, and professionally.
• Excellent oral and written communication skills.
• Proficiency in the use of Microsoft Office products.
• Organizational and time management skills.
• Working knowledge of the clinical research regulatory framework and institutional requirements.
• Demonstrate ability to convey ideas and information effectively.
• Analytical skills and good judgment

Work Environment

This job is operated in a professional, fast-paced medical clinic environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets and interacts with staff and patients

Physical Demands

The selected candidate must sit and use both hands for typing for extended periods, climb or balance, and stoop, kneel, crouch, or crawl periodically. Must be able to lift and/or move up to 30 pounds. Required to multitask, stay organized, and manage a large, fast-paced workload. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Travel

This position requires up to 50% local travel, including frequent travel to multiple clinic locations and the corporate office, which are located throughout Southern California.

Other Duties

Please note this is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

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