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.

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).

Senior Clinical Research Associate

Key skills