KEY RESPONSIBILITIES:

Site Management and Monitoring Activities:

• Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and sponsor SOPs.
• Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.
• Partner with Clinical Trial Liaison (CTL) and other sponsor functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) 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

Oversight Monitoring:

• Prepare and maintain Oversight Monitoring Plan
• Perform review of study metrics, assess  CRO Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits
• Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA
• Review site source documentation and verify accurate data capture (ALCOA principles)
• Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items

Documentation and Reporting:

• Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting.
• Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner.
• Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents).

Issue Management and Escalation:

• Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary.
• Track, trend, and report issues, escalating them to the appropriate teams when required.

Collaboration and Communication:

• Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.
• Actively participate in team meetings and process improvement initiatives to enhance study outcomes.

Inspection Readiness

• Support inspection readiness activities and ensure sites maintain data integrity and protocol deliverables

JOB REQUIREMENTS:

Bachelor's degree (or equivalent)

Experience:

• Minimum of 5 years of related experience for Snr CRA
• 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).

Skills:

• Effective communication and interpersonal skills to build relationships internally and externally.
• Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories.
• Demonstrated ability to deliver clear and concise written reports.
• Effective prioritisation and time management skills