CRA II, Malaysia

Syneos Health, Inc.; Kuala Lumpur; On-site; MYR 163,000 - 246,000; Full time

Job summary

A global biopharmaceutical solutions company in Kuala Lumpur is seeking a Clinical Research Associate to ensure clinical research studies comply with established practices. In this role, you will conduct monitoring activities, develop quality assurance tools, and manage project components, collaborating with diverse teams. Ideal candidates will hold a Bachelor's degree and have 2-4 years of clinical research experience, coupled with excellent communication and organizational skills. Experience with GCP guidelines is essential.

Benefits

Career development opportunities

Supportive and engaged management

Total rewards program

Qualifications

• Minimum of 2-4 years of experience in clinical research monitoring.
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Ability to work independently and manage multiple priorities.

Responsibilities

• Conduct on-site and remote monitoring of clinical research studies.
• Develop and implement tools, procedures, and processes for quality monitoring.
• Manage defined components of projects or processes within the area of responsibility.
• Ensure accurate and timely documentation of monitoring activities and findings.

Skills

Attention to detail

Strong analytical skills

Problem-solving abilities

Critical thinking

Excellent communication skills

Interpersonal skills

Strong organizational skills

Time management skills

Education

Bachelor's degree in a related field

Tools

Clinical trial management systems

Microsoft Office Suite

Job description

Updated: December 4, 2025
Location: Kuala Lumpur, 14, Malaysia
Job ID:25100418

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms.
• Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates.
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials.
• Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues.
• Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans.
• Collaborate with cross-functional teams to support clinical trial operations, including working 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.

Certifications

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred.

Necessary Skills

• 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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within Clinical Monitoring/CRA job family at the P21 level are responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, and may manage two or fewer employees. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education.