Clinical Research Associate II

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Requirements:

• Bachelor’s degree with 2 years of experience as a Clinical Research Associate or equivalent education and training.
• Ophthalmic experience is strongly preferred.
• Ability to assess protocol and GCP compliance.
• Strong attention to detail for reviewing investigator site files.
• Knowledge of federal regulations governing research and Good Clinical Practices.
• Ability to read and comprehend clinical research protocols.
• Proficiency with Excel, CTMS, and EDC.
• Multilingual communication skills are a plus.

Responsibilities:

• Develop strong site relationships and ensure continuity through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with regulations and protocols.
• Gain an in-depth understanding of study protocols and coordinate tasks for Site Readiness.
• Conduct site visits, including evaluation, initiation, monitoring, and close-out visits.
• Collect and monitor required regulatory documentation throughout the study.
• Communicate with site staff on protocol conduct and performance issues.
• Identify and resolve compliance problems, managing information in relevant systems.
• Support audit and inspection activities as needed.