Clinical Research Associate II
New
O
OraOphthalmic clinical research
Remote - USFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 2 years' experience as a Clinical Research Associate or equivalent combination of education, training, and experience
- Required Skills
- GCPMicrosoft Excel
Requirements
- Bachelor’s degree or an equivalent combination of education, training, and experience.
- Minimum 2 years of experience as a Clinical Research Associate.
- Strong knowledge of Good Clinical Practices (GCP) and federal regulations governing research.
- Demonstrated ability to verify source data to reported data.
- Proficiency with Excel, CTMS, and EDC systems.
- Strong attention to detail for investigator site file review.
- Ability to read and comprehend complex clinical research protocols.
- Ability to travel up to 75%.
- Ophthalmic clinical research experience is strongly preferred.
Responsibilities
- Develop strong site relationships and ensure continuity through all phases of the trial.
- Perform site management and monitoring activities in compliance with ICH-GCP, protocols, and local regulations.
- Participate in site selection, validation, and study start-up documentation review.
- Conduct on-site and remote monitoring visits, including initiation, interim, and close-out activities.
- Verify source data against reported data to ensure accuracy and completeness.
- Manage documentation in CTMS and eTMF systems.
- Identify and resolve site performance or compliance issues in collaboration with internal stakeholders.
- Support audit and inspection activities as required.
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