job title: Clinical trial specialist(Emerald clinical trials)

Roles and Responsibilities

• 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)

  About You

  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