Senior CRA

• Perform monitoring activities for initiation, conduct, recruitment, quality data collection, and timely completion of Oncology and Hematology clinical trials within Malaysia
• Deliver data within timelines and required quality standards
• Ensure adherence to monitoring procedures in accordance with GCP, ICH, local regulations, and SOPs
• Conduct pre-study, initiation, routine monitoring, closeout, co-monitoring, and Quality Oversight Visits as required
• Ensure study milestones are met, including study startup, recruitment, database analyses, and closeout
• Document monitoring activities and complete monitoring/QOV reports timely
• Assist with investigator/site identification and Ethics Committee submissions
• Facilitate clinical trial site contract and budget negotiation
• Manage site queries and communications
• Provide protocol and study training to assigned sites
• Evaluate site practices and escalate quality issues as appropriate
• Track regulatory submissions, recruitment, CRF completion, and data query resolution
• Collaborate with the CRA Group/CRM on recruitment and contingency plans
• Perform additional assigned tasks

• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medicine
• Thorough knowledge of clinical trial processes, ICH, and associated regulatory guidelines
• +1 year of monitoring experience in the pharmaceutical or CRO industry; over 4 years for SCRA
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in English (writing and speaking)

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant!)
• In-house and external learning and development opportunities
• Fantastic benefits program
• Dynamic, collaborative, supportive, inclusive, and fun team environment