Senior Clinical Research Associate
Location
Texas
Posted
2 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Research Associate
Parexel
• Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs. • Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely. • Partner with Clinical Trial Liaison (CTL) and other client functions to support site activation and deliverables. • Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct. • Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements. • Prepare and maintain Oversight Monitoring Plan. • Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA. • Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting. • Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary. • Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.
Job Requirements
- Bachelor's degree (or equivalent)
- Minimum of 5 years of monitoring experience
- Experience with Phase I Oncology studies
- Ability to travel to other regions for SWAT and/or oversight visits
- Strong analytical problem-solving skills and critical thinking abilities.
- Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA).
Benefits
- Health insurance
- Flexible work arrangements
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