Senior Clinical Research Associate

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Emerald Clinical

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2000

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Emerald Clinical is a leading global clinical research organization (CRO) founded in the Asia‑Pacific region that provides end‑to‑end clinical trial services to biopharmaceutical, medical device, and diagnostic companies. With about 25 years of experience and a team of 800+ operating across 40+ locations worldwide, Emerald Clinical manages trials across all phases including registration and post‑marketing studies, and offers clinical operations, project management, and trial staffing support. The company emphasizes scientific expertise, operational excellence, and global reach to support drug and device development.

📋 Description

• 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.

🎯 Requirements

• Qualifications in a related science or health care discipline. • Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with 2-5 experiences in on-site monitoring and site management experience is mandatory. • 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.

🏖️ Benefits

• 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.