Senior Clinical Research Associate
Our client, a well-established, full-service, and globally recognized Contract Research Organization (CRO), is currently seeking a dedicated and experienced Senior Clinical Research Associate (SCRA) to join their growing team in Malaysia.
Responsibilities:
- Oversee site performance, ensuring strong enrolment, data quality, and regulatory compliance while identifying risks and driving mitigation plans with Clinical Operations.
- Lead and support assigned CRAs through monitoring oversight, report review, and guidance on complex site issues, protocol deviations, and site‑level challenges.
- Serve as the main contact for all monitoring‑related inquiries and support investigators in meeting recruitment targets through tailored engagement strategies.
- Act as the primary CRA for at least one site to maintain firsthand understanding of study conduct and monitoring processes.
- Facilitate regular communication with CRAs, including KPI discussions, onboarding, training, mentoring, and co‑monitoring to assess their competencies.
- Collaborate closely with Project Managers, Medical, Data Management, Regulatory, and other stakeholders to inform timelines, address study barriers, and contribute to overall study decisions.
- Ensure continuous audit and inspection readiness, supporting internal audits, authority inspections, CAPA development, and smooth CRA handovers.
- Promote a culture of quality, compliance, and continuous improvement while managing assigned project responsibilities as delegated by the Project Manager.
Requirements:
Bachelor's degree in a relevant healthcare or life sciences field.
Minimum of 1 year of SCRA experience, with a strong background in on-site monitoring.
Excellent communication and interpersonal skills, with the ability to work effectively across diverse teams and cultures.
Willingness to travel frequently within Malaysia.
If you are interested in this role, please apply with your most updated CV attached.
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