Clinical Research Coordinator

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 SOPs.

- 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

Qualifications

- 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 job description 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.