We are seeking a skilled and experienced Contract Clinical Research Associate (CRA) to join our team in managing and monitoring clinical trials related to ophthalmic diseases, treatments, and medical devices. This position requires expertise in clinical trial processes, regulatory compliance, and strong collaboration with site personnel and clinical operations teams to ensure trials are conducted in adherence to international guidelines and local regulations.

Job Title: Contract Clinical Research Associate (CRA) Ophthalmology
Duration: 12 Months
Location: San Diego, CA

Key Responsibilities:

• Assist in identifying and selecting investigative sites for clinical trials.
• Conduct site initiation visits, providing training and education to site staff on study protocols, regulatory requirements, and best practices for handling and storing ophthalmic drugs and medical devices.
• Ensure site-specific recruitment strategies are in place to meet enrollment targets.
• Perform on-site and remote monitoring visits to ensure compliance with study protocols, data accuracy, and regulatory standards.
• Review source documents, case report forms (CRFs), and patient records for data integrity and consistency.
• Verify informed consent procedures and adherence to study protocols.
• Ensure clinical trial instruments and equipment are correctly calibrated, maintained, and used in accordance with study protocols.
• Ensure clinical trial sites adhere to applicable regulatory requirements (e.g., FDA, ICH, GCP) for ophthalmic drugs and medical devices.
• Maintain and audit the Investigator Site File to ensure it is up to date and compliant.
• Verify that patient qualifications align with study inclusion/exclusion criteria and that the correct investigational product is dispensed or implanted.
• Confirm full reconciliation of investigational product at the site level and monitor device-related safety concerns, escalating issues to the study sponsor as needed.
• Ensure proper storage, handling, and accountability of investigational drugs and medical devices.
• Monitor clinical supply levels to ensure they meet trial requirements.
• Verify accuracy and completeness of data collected at sites, including data generated by instruments/devices.
• Collaborate with the data management team to identify and resolve data discrepancies and issues.
• Ensure that all safety concerns are reported and managed by the Principal Investigator in compliance with regulatory and protocol standards.
• Conduct site close-out visits to confirm all study-related activities are completed and documented according to the protocol and regulatory requirements.
• Complete and submit thorough and accurate monitoring reports, including detailed follow-up letters to the sites.
• Maintain Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) to ensure audit readiness.

Skills:

• Strong understanding of ophthalmic diseases, treatments, and associated medical devices.
• Comprehensive knowledge of FDA, ICH, and GCP guidelines.
• Proficiency with clinical trial documentation tools and data management systems.

Education and Experience:

• Bachelor's degree in a related field (e.g., life sciences, nursing).
• Prior experience as a Clinical Research Associate, preferably in ophthalmology or a related therapeutic area.