Clinical Research Associate
The Judge Group Inc.

Location: REMOTE
Description:
Job Title: Contract Clinical Research Associate (CRA) - Ophthalmology

Job Summary:
As a Contract Clinical Research Associate (CRA) in ophthalmology, you will monitor and manage clinical trials focused on eye diseases, ophthalmic treatments, and medical devices. Your role will ensure compliance with international guidelines, local regulations, industry standards, and study protocols across multiple clinical trial sites.

Key Responsibilities:

Site Selection and Initiation:

• Assist in selecting investigative sites for clinical trials.
• Conduct site initiation visits to train staff on study protocols and regulatory requirements.
• Implement recruitment strategies to meet enrollment targets.

Monitoring and Site Management:

• Perform on-site and remote monitoring visits to ensure data quality and regulatory compliance.
• Review source documents, case report forms, and patient records.
• Verify the informed consent process and adherence to the study protocol.
• Ensure calibration and maintenance of trial instruments and equipment.
• Collaborate with the Clinical Operations Lead and Clinical Trial Team to resolve site issues.

Regulatory Compliance:

• Ensure trial sites comply with applicable regulatory requirements (e.g., FDA, ICH, GCP).
• Maintain an audit-ready Investigator Site File.

Investigational Product and Clinical Supplies Oversight:

• Verify subject qualification and ensure correct investigational product dispensing.
• Confirm full reconciliation of investigational products at the site level.
• Monitor safety and performance concerns related to devices and report them to the study sponsor.
• Ensure proper handling and accountability of investigational drugs and medical devices.

Data Management:

• Verify accuracy and completeness of data, including device-generated data.
• Collaborate with the data management team to address data-related issues.

Safety Reporting:

• Ensure all safety issues are communicated and managed by the Principal Investigator in accordance with regulatory and protocol requirements.

Close-Out Visits:

• Conduct close-out visits to finalize data collection and complete all study-related activities as per protocol and regulatory requirements.

Documentation and Reporting:

• Complete detailed monitoring reports, including site follow-up letters.
• Ensure that CTMS and eTMF are current and audit-ready.

Preferred Qualifications:

• Bachelor's degree in a related field (e.g., life sciences, nursing).
• Previous experience as a Clinical Research Associate, preferably in ophthalmology or a related area.
• Knowledge of ophthalmic diseases, treatments, and medical terminology, including medical devices.
• Strong understanding of clinical research regulations and Good Clinical Practice (GCP) guidelines.
• Excellent communication and interpersonal skills.
• Strong attention to detail and the ability to work independently as well as part of a team.
• Willingness to travel for on-site monitoring visits.
• Certification as a Certified Clinical Research Associate (CCRA) or similar credential is a plus.

Contact: atunstall@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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