Clinical Research Coordinator

Retina Associates of Western NY is a leading organization dedicated to advancing clinical research and delivering innovative solutions in healthcare. We are committed to improving patient outcomes and driving medical breakthroughs. We are looking for a highly organized and detail-oriented Clinical Studies Coordinator to join our team, with a strong focus on regulatory and compliance requirements.

Position Summary:The Clinical Studies Coordinator will play a vital role in the planning, coordination, and execution of clinical research studies. This role requires a deep understanding of clinical trial protocols, regulatory requirements, and compliance guidelines. The ideal candidate will ensure that all clinical studies are conducted in accordance with Good Clinical Practice (GCP) standards, federal and international regulations, and company policies.

Key Responsibilities:

• Study Coordination

• Coordinate day-to-day operations of clinical trials, including recruitment, scheduling, and follow-up with study participants.

• Ensure study activities adhere to the study protocol and regulatory guidelines.

• Regulatory Compliance

• Prepare, submit, and maintain all regulatory documents, including IRB/ethics committee applications, amendments, and renewals.

• Monitor studies to ensure compliance with Good Clinical Practice (GCP) standards and applicable federal, state, and local regulations.

• Work with the regulatory team to interpret and apply regulatory requirements to clinical studies and keep up-to-date with changes in regulations.

• Data Management and Reporting

• Oversee data collection to ensure accuracy, integrity, and confidentiality in accordance with regulatory standards.

• Prepare regular status reports on study progress and provide updates to principal investigators and sponsors.

• Documentation and Record Keeping

• Maintain accurate and detailed documentation of study activities, participant interactions, and study outcomes.

• Ensure all study documentation is audit-ready and compliant with regulatory and internal guidelines.

• Participant Interaction

• Obtain informed consent from study participants and educate them on study procedures and potential risks.

• Serve as a point of contact for participants throughout the study and address questions or concerns