Job Overview
Welcome to the Ocular Clinical Trials at Vision Optique. We are proud to lead the way in ocular clinical research and are committed to helping advance the future of eye care. Since 2020, we’ve conducted 20+ pre-clinical, Phase I-IV clinical trials, and we continue to actively enroll participants in new studies.
We are seeking an experienced Clinical Research Coordinator (CRC) who will work on site to help ensure that quality research is conducted in accordance with the Sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data.
The CRC will play a key role in managing day-to-day operations of optometry-related clinical studies, including participant recruitment, informed consent, study visits, data collection, and regulatory compliance. The ideal candidate has prior experience in clinical research, excellent organizational skills, and an interest in advancing vision science and ocular health.
Responsibilities
- Complete all sponsor-required and study-specific training (protocols, amendments, manuals, EDC/IVRS, and electronic systems) in a timely manner.
- Conduct study visits and protocol-required procedures with the PI/Sub-I, ensuring accurate and timely documentation per ALCOA-C standards.
- Perform study-related assessments (e.g., visual acuity testing, ocular imaging, intraocular pressure measurement) under PI supervision.
- Recruit, screen, and enroll eligible participants; obtain informed consent and ensure participant understanding of study procedures, risks, and benefits.
- Support subject retention through clear communication and engagement with research participants.
- Collect, enter, and verify data in eCRFs; resolve queries promptly per sponsor and site guidelines.
- Manage study visit scheduling, follow-ups, and participant communications.
- Maintain regulatory binders and prepare/submit required IRB and sponsor documentation on schedule.
- Ensure proper handling of investigational product (IP), including storage, temperature monitoring, calibration, inventory, and compliance with pharmacy manuals.
- Liaise with investigators, research staff, administrative personnel, participants, sponsors, CROs, and monitors to ensure smooth study operations.
- Adhere to GCP, FDA, IRB, and institutional regulations at all times.
- Contribute to staff training, study reports, and presentations as needed.
- Perform additional tasks as assigned by management.
Requirements
- Bachelor’s degree in life sciences, healthcare, optometry, or related field
- 1–2 years of experience in clinical research or healthcare setting
- Knowledge of clinical research regulations (GCP, ICH guidelines, FDA) with GCP and Biomed certifications
- Strong organizational, interpersonal, and communication skills
- Ability to manage multiple projects and maintain attention to detail
Preferred:
- Certified Clinical Research Coordinator (CCRC) or equivalent certification
- Previous experience in ophthalmology or optometry clinical trials
- Familiarity with ophthalmic diagnostic tools and procedures
- Phlebotomy skills and/or experience with biological sample collection
Pay: $22.00 - $25.00 per hour
Benefits:
- Employee discount
- Health insurance
- Paid time off
Work Location: In person