Clinical Trial Specialist

Emerald Clinical Trials Inc.

Gastonia, NCFull-timePosted Apr 30, 2026

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Qualifications

  • •College / University diploma / degree; or at least 2 years related experience and/or training; or equivalent combination of education and experience

Responsibilities

  • •You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology
  • •Global Reach, Local Expertise
  • •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
  • •The CTS works closely with the project team to help manage clinical trial feasibility processes and coordinate clinical trial start‑up activities, including collection of essential documents for site initiation/start‑up, submissions to central IRBs/Ethic Committees, supporting site staff in the submission to local IRBs/Ethic Committees and changes to Informed Consent Forms (ICFs)
  • •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
  • •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
  • •Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments
  • •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
  • •15 more items(s)
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