Clinical Research Associate, Malaysia

Emerald Clinical; Malaysia; Hybrid; MYR 85,000 - 120,000; Full time

Benefits offered by this job

Hybrid or remote work

Career growth

Wellbeing programs

Global opportunities

Job summary

Emerald Clinical Trials is seeking a Clinical Research Associate 2 to join our Clinical Operations team. You will oversee site management, perform monitoring activities, and provide regulatory support to ensure trials run on time, within scope, and in full compliance.

The ideal candidate holds a tertiary science or health care qualification and has at least two years of on-site monitoring experience in academic, CRO, or pharmaceutical settings.

Qualifications

• Tertiary qualification in a related science or health care discipline.
• Minimum 2 years on-site monitoring and site management experience in academic, CRO, or pharmaceutical environments.
• Renal and/or Oncology trial experience is a plus.
• Solid understanding of ICH-GCP guidelines and regulatory requirements.

Responsibilities

• Coordinate investigator and site identification, feasibility, and selection for trials.
• Complete monitoring activities per Monitoring Plan and prepare visit reports.
• Prepare, plan, and conduct site initiation visits and site evaluations.
• Prepare regulatory packages and liaise with regulatory colleagues; manage Ethics Committee submissions.

Skills

On-site monitoring

Site management

Regulatory knowledge

Negotiation skills

Communication

Education

Bachelor's degree in a related science or health care

Job description

Who We Are

Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies.

With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.

Global Expertise. Local Insight. Real Impact.

Our 1000+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.

About The Role

The Clinical Research Associate 2 is a member of the Clinical Operations group at Emerald Clinical. The Clinical Operations group is responsible for site management, monitoring tasks, and the operational support of clinical trials. The group allocates resources to projects as appropriate to assist with implementing project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs).

Your Responsibilities

• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
• Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
• Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection.
• Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
• Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
• Prepare, plan, organize, and conduct site initiation visits.
• Develop and maintain appropriate monitoring tools and project-specific documents.
• Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines. Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
• Reconcile contents of in-house TMF and site’s Investigator Site Files.
• Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
• Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
• Support strategies to boost recruitment efforts.

About You

• Tertiary qualifications in a related science or health care discipline.
• Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with more than 2 years' experience in on-site monitoring and site management experience is mandatory
• Experience in Renal and/or Oncology clinical trials is a plus.
• Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
• Display competence in the following technical areas: ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
• Demonstrate competence in the following business skill areas: negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
• Demonstrate solid interpersonal communication, presentation skills, and flexibility to work well within a multi-disciplinary team both autonomously and with a wide range of varying stakeholders
• Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.
• Ability and willingness to travel

Disclaimer

This requisition is currently open for talent pooling purposes. The role is not yet available, but we will review applications and contact suitable candidates as soon as the position becomes available.

Why Join Us?

At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here’s What Makes Us Stand Out

• Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.
• Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.
• Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

What We Offer

We understand that great work happens when people feel valued and supported. That’s why we provide:

• Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
• Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
• Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
• Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
• Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

We are an equal-opportunity employer and encourage applications from all qualified candidates.