Clinical Research Associate 2

Emerald Clinical; Selangor; On-site; MYR 60,000 - 90,000; Full time

Job summary

A global Contract Research Organization is seeking a Clinical Research Associate 2 to join their Clinical Operations group in Malaysia. In this role, you will coordinate clinical trial activities, including site selection, monitoring, and regulatory compliance. The ideal candidate will have experience in clinical trials and a strong ability to train trial site personnel. This position requires a detail-oriented individual who can effectively manage site budgets and ensure timely communications with investigators. Competitive compensation package offered.

Qualifications

• Experience in coordinating clinical trials and site management.
• Strong understanding of regulatory requirements and SOPs.
• Ability to train and motivate trial site personnel.

Responsibilities

• Coordinate site identification and feasibility assessments.
• Complete monitoring activities per the Monitoring Plan.
• Prepare and conduct site evaluation and initiation visits.
• Negotiate site budgets and manage contracts.

Job description

At Emerald Clinical, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing.

Our therapeutic expertise spans renal, cardiometabolic, and oncology—areas where we make a significant impact on improving global health.

At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need.

About The Role

The Clinical Research Associate 2 (CRA2) 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 theaasystemthe trial.
• Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
• Prepare,ोल, 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-aga 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.