Cra 2 - Senior 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 Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).