Clinical Research Associate

MerckMYS - Selangor - Petaling Jaya (Ascent Paradigm)onsiteSalary not postedView the original posting at Merck ↗

Job Description The Clinical Research Associate (CRA) is accountable for the performance and compliance of assigned clinical study protocols and investigational sites within the country. Under the oversight of the CRA Manager, the CRA ensures that study conduct complies with ICH-GCP guidelines, local regulatory requirements, sponsor policies and procedures, quality standards, and adverse event reporting requirements. The CRA serves as the primary site contact and site manager throughout all phases of a clinical research study, assuming overall responsibility for assigned sites. The role also contributes to the development of clinical research capabilities by identifying and cultivating new investigator sites and participating as a subject matter expert (SME) in monitoring processes and systems. Key Responsibilities Site Management & Monitoring Develop and maintain strong relationships with investigational sites throughout all phases of the clinical trial lifecycle. Perform site management and monitoring activities in accordance with: ICH-GCP guidelines Sponsor SOPs Local laws and regulations Study protocol requirements Site Monitoring Plans and associated study documents Gain a comprehensive understanding of study protocols and related procedures. Coordinate and manage site readiness activities in collaboration with cross-functional stakeholders. Participate in site selection, qualification, and validation activities. Conduct remote and on-site monitoring activities to ensure: Data generated at sites are complete, accurate, and unbiased. Participant rights, safety, and well-being are protected. Conduct site visits including: Site qualification/validation visits Site initiation visits (SIV) Interim monitoring visits Close-out visits Prepare clear, comprehensive, and timely visit reports and documentation. Regulatory & Compliance Management Collect, review, and maintain required regulatory documentation throughout study startup, maintenance, and close-out phases. Ensure compliance with applicable regulations, study protocols, and quality standards. Support audit and inspection readiness activities. Assist with or lead audit and inspection activities when required. Perform co-monitoring visits as appropriate. Maintain accurate and timely documentation within CTMS, eTMF, and other clinical systems. Site Performance & Issue Management Communicate with investigators and site personnel regarding: Protocol implementation Patient recruitment and retention Protocol deviations Regulatory documentation Audits and inspections Overall site performance Identify, assess, and resolve site performance, quality, and compliance issues. Escalate risks and concerns through established escalation pathways when appropriate. Conduct root cause analyses and implement preventive and corrective actions (CAPAs). Monitor recruitment performance and support enrollment strategies. Cross-Functional Collaboration Collaborate closely with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, ethics committees, and regulatory authorities. Support study delivery through effective stakeholder management and coordination. Contribute to team development by acting as: Subject Matter Expert (SME) Mentor or buddy Best-practice contributor Site Development Support country clinical research strategies by identifying and evaluating new investigator sites. Partner with investigators and sites to enhance clinical research capabilities and performance. Expand and strengthen the local clinical research network. Travel Requirements Domestic and international travel of approximately 65%–75% of working time. Expected travel frequency of approximately 2–3 days per week. Core Competencies Clinical & Technical Expertise Fluency in local language(s) and English, both written and verbal. Strong understanding of: Clinical research processes Clinical trial phases ICH-GCP guidelines Country-specific clinical rese

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