Clinical Research Associate II

Overview

Emerald Clinical is a global, full-service Contract Research Organization (CRO) with a heritage in the Asia-Pacific region. We advance 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. The Clinical Research Associate II (CRA2) is a member of the Clinical Operations group and is responsible for site management, monitoring tasks, and the operational support of clinical trials.

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 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.

Qualifications / 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 3 – 5 years of monitoring and site management experience.
• Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
• Display competence in: 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 stakeholders.
• Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.
• Ability and willingness to travel.

Why Join Us / What We Offer

• 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.
• 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.

Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. Location: Singapore .

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

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