When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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