Syneos Health is looking for a Clinical Research Associate II (CRA II) in Malaysia. In this role, you will be responsible for ensuring the integrity and compliance of clinical research studies through hands-on monitoring and process development within a team dedicated to changing lives.
What You'll Do
- Conduct 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 your 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.
What We're Looking For
- 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.
- 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.
Nice to Have
- Certified Clinical Research Associate (CCRA) or equivalent certification.
Technical Stack
- Clinical trial management systems
- Microsoft Office Suite
Team & Environment
You will collaborate with cross-functional teams to support clinical trial operations.
Benefits & Compensation
- Career development and progression opportunities.
- Supportive and engaged line management.
- Technical and therapeutic area training.
- Peer recognition programs.
- Comprehensive total rewards program.
Work Mode
This is a local-country position based in Malaysia.
Syneos Health is an equal opportunity employer.
