Clinical Research Associate Ii

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.
Why Join Us?At our core, Emerald Clinical 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.
About the RoleThe 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 ResponsibilitiesCoordinate 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 YouTertiary qualifications in a related science or health care discipline.Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with 3 – 5 experiences in monitoring and site management experience is mandatoryDemonstrate 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 stakeholdersAbility to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.Ability and willingness to travel
What We OfferWe 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.
Interested? Apply now and help us achieve our mission to improve the health of millions worldwide.