[Hiring] Clinical Research Associate II @5043 Syneos Health Malaysia Sdn. Bhd.

Role Description

This role involves conducting on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices.

• Review study protocols, informed consent forms, and case report forms
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Create monitoring plans, checklists, and templates
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Participate in the development of standard operating procedures (SOPs) and training materials
• Manage defined components of projects or processes within the area of responsibility
• Coordinate site visits, track study progress, and resolve issues
• Ensure accurate and timely documentation of monitoring activities and findings
• Write monitoring reports, follow-up letters, and action plans
• Collaborate with cross-functional teams to support clinical trial operations
• Work with investigators, site staff, and other stakeholders to ensure smooth study conduct

Qualifications

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Requirements

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred
• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Benefits

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Commitment to a Total Self culture