CRA II - Sr. CRA I

Role Summary:

The Clinical Research Associate (CRA) is responsible for site monitoring and management activities for clinical trials conducted in Malaysia, ensuring compliance with ICH-GCP, Fortrea SOPs, local regulatory requirements, and Sponsor expectations.

Key Responsibilities

• Perform site monitoring visits including Site Initiation, Routine Monitoring, and Close-Out Visits

• Ensure subject safety, protocol compliance, and informed consent adherence

• Conduct source document review, SDV, eCRF review, and query management

• Ensure data integrity, accuracy, and regulatory compliance

• Manage site regulatory documents, eTMF, and study files

• Verify Investigational Product (IP) storage, accountability, and reconciliation

• Track and follow up on Serious Adverse Events (SAEs)

• Maintain audit and inspection readiness at site level

• Collaborate with study teams to meet project timelines and deliverables

• Act as Lead CRA on assigned studies, when applicable

Qualifications & Experience

• Degree in Life Sciences, Nursing, Pharmacy, or related health discipline (Equivalent experience may be considered)

• Minimum 2 years of independent Clinical Monitoring (CRA) experience

• Strong knowledge of ICH-GCP and clinical trial processes

• Understanding of Malaysian regulatory requirements

• Fluent in English (written and spoken)

• Experience using eClinical systems (CTMS, EDC, eTMF)

Preferred

• Phase I / Early Phase monitoring experience

• Strong communication, organization, and problem-solving skills

• Ability to work independently in a matrix environment

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