The SrCRA role is responsible for supporting monitoring and site management activities for the client Sponsored studies. Site monitoring and site management activities are conducted according to ICH GCP, applicable country/local regulations and client SOPs. Site interactions are conducted both on-site and off-site with documented interactions recorded in CTMS. The role involves collaboration with cross-functional clinical study teams and investigator site personnel to ensure study deliverables are met efficiently and effectively. The SrCRA is also responsible for the oversight of activities carried out at investigator sites where the monitoring may be supported by a CRO partner through the review of operational data and metrics.
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 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 (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 prioritization and time management skills
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