Senior Clinical Research Associate
O
OraOphthalmic Clinical Research
Remote - USFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 3 years
- Required Skills
- Microsoft Excel
Requirements
- Bachelor’s degree or equivalent combination of education, training, and experience.
- 3 years of experience as a Clinical Research Associate.
- Advanced knowledge of federal regulations governing research and Good Clinical Practices (GCP).
- Ability to understand and assess investigative site capabilities and protocol compliance.
- Proficiency with Excel, CTMS, and EDC systems.
- Strong attention to detail for reviewing investigator site files and test article management.
- Ability to read and comprehend complex clinical research protocols.
- Ability to travel up to 75%.
Responsibilities
- Develop and maintain strong relationships with clinical sites throughout the trial.
- Perform clinical study site management and monitoring activities in compliance with ICH-GCP, protocols, and regulations.
- Provide input on site selection and validation activities.
- Conduct site visits including evaluation, initiation, monitoring, and close-out visits.
- Review and monitor regulatory documentation for study start-up, maintenance, and close-out.
- Manage and maintain data and documentation in CTMS, eTMF, and other systems.
- Identify and resolve site performance, quality, or compliance issues.
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