Clinical Research Associate - Malaysia

Planet Pharma; Selangor; On-site; MYR 60,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Employee Assistance Programme (TELUS)

Job summary

Planet Pharma is seeking a Clinical Research Associate in Malaysia to lead site initiation, monitoring, and close-out of Phase II–IV trials. You will ensure compliance with ICH-GCP and regulatory standards while coordinating with sponsors and global teams. The role requires strong documentation, budget awareness, and potential mentoring of junior CRAs in a fast-paced, international environment. A relevant degree and travel up to 60% are expected.

Qualifications

• 2+ years monitoring experience in Phase I-III trials.
• Bachelor's degree in Medicine, Science, or equivalent.
• Experience in start-up and close-out procedures.
• Strong knowledge of ICH-GCP guidelines.

Responsibilities

• Set up, monitor, and close studies with thorough documentation.
• Submit protocols and regulatory documents for ethics/IRB approval.
• Address sponsor queries and ensure effective communication.
• Monitor study costs and budget adherence.
• Prepare study documentation and conduct feasibility analyses.
• Mentor junior CRAs as needed.

Skills

Clinical trials monitoring

ICH-GCP knowledge

English communication

Travel readiness

Education

Bachelor's degree in Medicine/Science

Tools

EDC systems

CTMS

Job description

Join a Leading Healthcare Organization in Malaysia as a Clinical Research Associate and be a Catalyst in Transforming Medical Innovation! Are you passionate about advancing medical science and making a real difference? A prominent global healthcare organization is seeking dedicated Clinical Research Associates (CRAs) in Malaysia to join their dynamic team. This is your chance to work on groundbreaking clinical trials that shape the future of medicine, collaborating with top-tier pharmaceutical partners and contributing to life-changing therapies worldwide.

About The Role

As a Clinical Research Associate at this organization, you will play a pivotal role in the execution of Phase II-IV clinical trials. You’ll operate within a fast-paced, collaborative environment, overseeing site initiation, monitoring, and close-out, while ensuring compliance with ICH-GCP guidelines and regulatory standards. Partnering with a renowned global pharmaceutical company, you’ll help bring innovative medicines to market, supporting patients and healthcare systems alike. Your expertise will facilitate seamless study processes, optimize study efficiency, and mentor new team members, all while enjoying a rewarding career development journey.

What You Will Be Doing

• Independently set up, monitor, and close studies while maintaining comprehensive documentation and timely reports
• Submit protocols, consent forms, and regulatory documents for ethics and IRB approval
• Address sponsor queries effectively, ensuring seamless communication
• Monitor study costs to ensure budget adherence
• Prepare and review study documentation and conduct feasibility analyses for new proposals
• Potentially assist in training and mentoring fellow CRAs to uphold high standards across teams

Required Skills

• Minimum of 2+ years monitoring experience in Phase I-III clinical trials
• Bachelor's degree in Medicine, Science, or an equivalent qualification
• Proven experience in medium-sized study start-up and close-out procedures
• Strong knowledge of ICH-GCP guidelines and medical data evaluation
• Excellent written and verbal communication skills in English
• Ability to travel at least 60% domestically and internationally; valid driver's license required

Nice To Have Skills

• Previous experience working on global or multinational clinical studies
• Additional language skills relevant to Malaysia or the APAC region
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
• Proven leadership in mentoring or training junior CRAs

Preferred Education And Experience

• Bachelor's degree in a healthcare, scientific, or related field
• At least 2 years' monitoring experience in Phase I-III trials, ideally in medium-scale studies
• Familiarity with international regulatory requirements and clinical trial processes

Other Requirements

• Availability to travel regularly, including international and domestic trips, with a valid driver's license
• Ability to work independently and proactively in a fast-paced team environment

Why Choose This Organization?

At this organization, they value their people and their contributions. They offer competitive salaries, comprehensive benefits, and a supportive environment that fosters growth and innovation. Their benefits package includes generous leave entitlements, health insurance options, retirement plans, and access to their global Employee Assistance Programme via TELUS Health, ensuring your well-being and work-life balance.