Allucent is hiring a
Clinical Trial Associate

Summary

Join our A-team as a Clinical Trial Associate at Allucent, providing primary administrative support to clinical study teams and ensuring the conduct of international clinical studies in accordance with regulatory laws and guidelines.

Responsibilities

• Performs quality check of documents prior to eTMF submission to ensure the documents meet specifications to be complete and accurate for filing
• Acts as Document Submitter and submits country and site level documents to eTMF Document Inbox. Resolves rejections
• Assists with resolution of periodic QC findings for country and site eTMF
• Maintains study wet-ink documents temporarily in the local office and prepares shipment to the client at the end of the study
• Communicates with the TMF Lead / Project Specialist to follow-up on country and site level eTMF status
• Updates Expected Documents List (EDL) in eTMF for the country and site level
• Maintains Public Folders in accordance with the Study Correspondence Management Plan
• Prepares and distributes Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs) or other files needed for Site Initiation Visits (SIVs)
• Prepares and maintains QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation to site visits and paperwork after site visits
• Assists CRA with reconciliation of ISF/PSF vs. TMF and cooperates with TMF Specialist and PS (Project Specialist)/TMF Lead to ensure inspection readiness of the TMF
• Assist CRAs /CTLs with query resolution and aged action item metrics follow up internally
• Performs translations, back-translations or verification of translations of study documentation when needed
• Accurately updates and maintains site level CTMS, as needed
• If needed, assists the project team with CTMS reports at requested intervals to follow-up on pending entries
• Contribute to other areas of business as required