Clinical Research Associate
Behavioral Health Market Context
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Job Description
achelor's degree in life sciences, nursing, or a related field; advanced degree preferred
Minimum of 3+ years of clinical operations experience in biotech, pharma, or CRO environments
Prior experience in site management and CRO oversight strongly preferred
Strong knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements
Experience with EDC systems, CTMS, eTMF, and safety reporting processes
Minimum of 3+ years of clinical operations experience in biotech, pharma, or CRO environments
Prior experience in site management and CRO oversight strongly preferred
Strong knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements
Experience with EDC systems, CTMS, eTMF, and safety reporting processes
Qualifications
- •Minimum of 3+ years of clinical operations experience in biotech, pharma, or CRO environments
- •Strong knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements
- •Experience with EDC systems, CTMS, eTMF, and safety reporting processes
Benefits
Responsibilities
- •Support site initiation, ongoing management, and close-out activities in accordance with study timelines
- •Ensure compliance with study protocol, ICH-GCP, FDA regulations, and company SOPs
- •Provide oversight of CRO CRAs and site management activities, and maintain a compliant Trial Master File
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