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.