Clinical Trial Specialist

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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.

The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB/Ethic Committee requirements, and applicable SOPs and guidelines. They support the project manager, clinical trial manager and clinical operations management related to the project startup, maintenance, and close-out activities in specified administrative functions including Trial Master File set-up and maintenance.

• Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project
• Increase proficiency in uploading and maintaining TMF files and folders in George Clinical's file-sharing system by project as assigned
• Serve as second reviewer for TMF QC
• May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight
• Assist with/complete end of study TMF filing (including site close out documents), QC and archival
• Further develop skills in preparing and participating in audit responses
• Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables
• Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned
• Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned
• Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable
• Assist with presenting final feasibility results to PM team and/or Sponsor
• Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs)
• Submit final EDPs to sponsor or CTM/PM as required
• Supports site staff in the submission to Local IRBs/ECs and performs review of ICFs (initial and updated)
• Supports site staff in the submission to Central IRBs/ECs, performs review of ICFs (initial and updated) and submits on behalf of sites (if applicable)

• 2-3 years' experience as CTS is mandatory
• Tertiary qualifications in a related science or health care discipline is preferred
• Exposure to medical terminology and physiology preferred
• Exposure to ICH/GCP, ethical and regulatory requirement

At our core, Emerald Clinical Trials 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.

We 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.

We are an equal-opportunity employer and encourage applications from all qualified candidates

• Not Applicable

• Other

• Research, Analyst, and Information Technology

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