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Clinical Trial Associate II

hace 2 meses

Zaragoza, Zaragoza, España Allucent A tiempo completo
About the Role

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are seeking a highly organized and detail-oriented Clinical Trial Associate II to join our team. As a Clinical Trial Associate II, you will be responsible for providing primary administrative support to our clinical study teams at the country/site level, ensuring that clinical trials are conducted in accordance with international regulatory and local regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures.

Key Responsibilities
  1. Document Quality Control: Perform quality checks of documents prior to eTMF submission to ensure they meet specifications, are complete, and accurate for filing.
  2. Document Submission: Act as Document Submitter and submit country and site level documents to eTMF Document Inbox, resolving any rejections.
  3. Periodic QC Findings: Assist with the resolution of periodic QC findings for country and site eTMF.
  4. Study Documentation: If applicable, maintain study wet-ink documents temporarily in the local office and prepare shipment to the client at the end of the study.
  5. Communication: Communicate with the TMF Lead/Project Specialist to follow up on country and site level eTMF status.
  6. Expected Documents List: Update Expected Documents List (EDL) in eTMF for the country and site level.
  7. Public Folders: Maintain Public Folders in accordance with Study Correspondence Management Plan.
  8. Investigator Site Files: Prepare and distribute Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs), or other files needed for Site Initiation Visits (SIVs).
  9. QC/Inventory Checklists: Prepare and maintain QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation for site visits and paperwork after site visits.
  10. Query Resolution: Assist CRA with reconciliation of ISF/PSF vs. TMF and cooperate with TMF Specialist and PS (Project Specialist)/TMF Lead to ensure inspection readiness of the TMF.
  11. Translation Services: Perform translations, back-translations, or verification of translations of study documentation when needed.
  12. CTMS Updates: Accurately update and maintain site level CTMS, as needed.
  13. CTMS Reports: Assist the project team with CTMS reports at requested intervals to follow up on pending entries.
  14. Study Trackers: Prepare and maintain country and sites related study trackers, as needed.
  15. Teleconferences: May be assigned to attend project specific teleconferences, prepare, and deliver TC minutes as requested.
  16. Clinical Trial Supplies: Prepare and distribute clinical trial supplies to the investigational sites and maintain tracking information.
  17. Site Communication: Communicate with sites regarding trial start-up, conduct, and close-out administrative activities.
  18. Feasibility and Site Identification: May participate in feasibility and/or site identification activities.