Clinical Trial Specialist

Overview

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. Our success is driven by combining global reach with local knowledge, working with on-the-ground teams to ensure diverse, representative patient recruitment and faster results that bring therapies to patients in need.

About The Role

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. The CTS supports the project team to ensure trials are conducted according to Federal Regulations, ICH guidelines, project plans, IRB / Ethics Committee requirements, and applicable SOPs. They support the project manager, clinical trial manager, and clinical operations management related to startup, maintenance, and close-out activities, including Trial Master File (TMF) setup and maintenance.

Your Responsibilities

• Increase proficiency in Trial Master File (TMF) setup 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
• Work 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
• Assist the sites in preparation, planning, organizing and collecting essential document packets (EDPs)
• Submit final EDPs to sponsor or CTM / PM as required
• Support site staff in the submission to Local IRBs / ECs and perform review of ICFs (initial and updated)
• Support site staff in the submission to Central IRBs / ECs, perform review of ICFs (initial and updated) and submit on behalf of sites (if applicable)

About You

Why Join Us?

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.

What Makes Us Stand Out

What We Offer

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

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

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