Clinical Research Associate

Clinical Research Associate

MSD invites a Clinical Research Associate (CRA) to manage and monitor clinical study sites in Malaysia, ensuring compliance with ICH / GCP, local regulations, and company SOPs. The CRA will serve as the primary site contact, drive site performance, and contribute to continuous process improvement.

Job Description

Accountable for performance and compliance of assigned protocols and sites. Acts as primary site contact and manager throughout all phases of a clinical research study, guaranteeing study conduct aligns with regulatory and internal standards.

Responsibilities

• Develop strong site relationships and ensure continuity throughout all trial phases.
• Perform site management / monitoring activities in compliance with ICH‑GCP, Sponsor SOPs, local laws, protocol, monitoring plan, and related documents.
• Gain an in‑depth understanding of the study protocol and related procedures.
• Coordinate and manage tasks in collaboration with other sponsor roles to achieve Site Ready status.
• Participate and provide input on site selection and validation activities.
• Perform remote and on‑site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate, and unbiased.
• Protect subjects’ rights, safety, and well‑being.
• Conduct validation, initiation, monitoring, and close‑out visits, recording clear, comprehensive, and timely visit and non‑visit contact reports.
• Collect, review, and monitor required regulatory documentation for study start‑up, maintenance, and close‑out.
• Communicate with investigators and site staff on protocol conduct, recruitment, retention, deviations, documentation, audits / inspections, and overall site performance.
• Identify, assess, and resolve site performance, quality, or compliance problems, escalating per the CRA Escalation Pathway with CRA Manager, CRM, TA Head, and CRD as needed.
• Collaborate internally with GCTO, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, and externally with vendors and IRB / IEC and regulatory authorities.
• Maintain information and documentation in CTMS, eTMF, and other systems according to timelines.
• Share best practices and provide training as a process SME to strengthen the CRA team.
• Support or lead audit / inspection activities as required.
• Contribute to identifying new potential sites, working with them to develop strong clinical research capabilities.
• Mentor junior CRAs and co‑monitor visits where appropriate.

Extent of Travel

Qualifications, Skills & Experience

Behavioural Competency Expectations

Experience Requirements

Preferred Education

What We Look For …

Imagine starting each day with a role that helps save and improve lives worldwide. You will bring empathy, creativity, digital mastery, or scientific brilliance to a diverse team that pursues hope for patients worldwide. Join us and make an impact today.

Equal Opportunity

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Job Details

Seniority level : Not applicable

Employment type : Full‑time

Job function : Research, Science, and Health Care Provider

Industries : Biotechnology Research, Pharmaceutical Manufacturing, Veterinary Services

Requisition ID : R

Job Posting End Date

11 / 29 / 2025

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