Senior Clinical Research Associate
5 days ago
Unlocking Clinical Trial Success
The Early Clinical Development Senior Clinical Research Associate will be responsible for conducting monitoring activities for multiple client-sponsored studies, adhering to Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and client Standard Operating Procedures (SOPs).
Key Responsibilities:
- Perform site management activities to ensure compliance with the protocol, monitoring plan, GCP, ICH, and SOPs.
- Monitor clinical trial quality and site management for client-sponsored studies.
- Conduct site qualification, initiation, interim, and close-out visits.
- Ensure sites meet performance expectations related to recruitment, enrollment, and retention.
- Review site source documentation, case reports, and verify accurate data capture.
- Ensure timely submission of study documentation and perform drug accountability, reconciliation, and destruction.
- Identify and record protocol deviations.
- Maintain ongoing communications with site personnel and analyze issues to make informed decisions.
Requirements:
- Minimum 5 years of relevant industry experience.
- Bachelor's Degree or equivalent.
Parexel is an Equal Opportunity Employer
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