CRA II Sr. CRA I

Kuala Lumpur - Malaysia

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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

Learn more about our EEO & Accommodations request here.

Required Experience:

Senior IC

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 ResponsibilitiesPerform site monitoring v...