Clinical Research Associate

Merck; Petaling Jaya; On-site; MYR 120,000 - 180,000; Full time

Job summary

Merck is seeking a Clinical Research Associate (CRA) responsible for ensuring performance and compliance of assigned clinical study sites within the country, adhering to ICH-GCP, local regulations, and sponsor policies. The CRA acts as primary site contact and oversees site readiness, monitoring, and report generation.

You will collaborate with cross-functional teams, support regulatory documentation, manage site performance, and contribute to audit readiness.

Qualifications

• Fluency in local language(s) and English, both written and verbal.
• Strong understanding of clinical research processes and GDP.
• Proven site management and patient recruitment experience.
• Familiarity with ICH-GCP guidelines and regulatory expectations.

Responsibilities

• Develop and maintain strong relationships with investigational sites throughout all phases of the clinical trial lifecycle.
• Perform site management and monitoring in line with ICH-GCP, sponsor SOPs, and local regulations.
• Prepare clear, timely visit reports and documentation.
• Maintain regulatory documentation through study startup to close-out.
• Identify and resolve site performance and compliance issues.
• Collaborate with country operations, regulatory affairs, and other stakeholders.

Skills

Site management

Monitoring

Regulatory compliance

Audit readiness

Data review & analysis

CTMS/eTMF proficiency

Cross-functional collaboration

Travel readiness

Communication skills

Problem solving

Tools

CTMS

eTMF

Microsoft Office

Mobile monitoring tools

Job description

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 research regulations

Knowledge of global and regional clinical research requirements.

Strong understanding of Good Documentation Practices (GDP).

Proven site management and patient recruitment experience.

Demonstrated monitoring expertise and sound professional judgment.

Ability to analyze data and performance metrics and take appropriate action.

Systems & Technology

Proficiency in Microsoft Office applications.

Experience using clinical systems such as CTMS, eTMF, and mobile monitoring tools.

Ability to quickly adopt new technologies and applications.

Problem Solving

Ability to manage complex issues and work in a solution-oriented manner.

Experience conducting root cause analyses and implementing corrective and preventive actions.

Strong risk assessment and decision-making capabilities.

Behavioral Competencies

Excellent time management and organizational skills.

Strong interpersonal and communication skills.

Effective conflict resolution and problem-solving abilities.

Ability t