Get AI-powered advice on this job and more exclusive features.At Emerald Clinical Trials, 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 II (CRA II) 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 other tracking and reporting tools.Support strategies to boost recruitment efforts.About You
Bachelor’s degree in life sciences or a health-related field.Previous experience as a CRA for Pharma or CRO.Fluent in English and Spanish.Practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.Competence in ethical and participant safety considerations, site start-up and conduct management, risk management, quality management, supply management, scientific concepts, clinical research design, and issue escalation management.Skills in negotiation, conflict resolution, critical thinking, problem-solving, decision-making, and strategic thinking.Strong interpersonal communication, presentation skills, and flexibility to work within a multi-disciplinary team and with diverse stakeholders.Ability and willingness to travel.Why Join Us?
At Emerald Clinical Trials, we are committed to transforming clinical research by putting people first—patients and employees alike. Join our team to be part of a global network of passionate professionals working to deliver better research and outcomes worldwide.What Makes Us Stand Out
Purpose-Driven Work:
Contribute to clinical trials that improve lives, focusing on renal, cardiometabolic, and oncology therapies.Global Reach, Local Expertise:
Engage with local communities, building trust and meaningful relationships for each trial.Collaboration and Innovation:
Thrive in a culture that values diverse perspectives and creative solutions to global health challenges.What We Offer
We believe great work happens when people feel valued and supported. Our offerings include:
Competitive Compensation:
Salary and benefits tailored to your skills and experience.Flexibility:
Hybrid or remote work options depending on your role and location.Career Growth:
Access to learning opportunities and a global network of scientific leaders.Employee Wellbeing:
Programs promoting work-life balance, health, and team connection, including engagement surveys, recognition, and team-building events.Global Opportunities:
Exposure to diverse projects and international clients.If you are interested, apply now and help us improve health outcomes for millions worldwide.We are an equal-opportunity employer and encourage applications from all qualified candidates.
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