Clinical Trial Associate II

hace 5 días

Madrid Centro, Madrid, España Allucent A tiempo completo
About the Role

We are seeking a highly organized and detail-oriented Clinical Trial Associate II to join our team at Allucent. As a Clinical Trial Associate II, you will play a critical role in supporting the conduct of international clinical studies, ensuring compliance with regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures.

Key Responsibilities
  1. Document Management: Perform quality checks on documents prior to eTMF submission to ensure completeness and accuracy. Submit country and site level documents to eTMF Document Inbox and resolve rejections.
  2. eTMF Maintenance: Assist with resolution of periodic QC findings for country and site eTMF. Maintain study wet-ink documents temporarily in the local office and prepare shipment to the client at the end of the study.
  3. Communication and Collaboration: Communicate with the TMF Lead/Project Specialist to follow-up on country and site level eTMF status. Update Expected Documents List (EDL) in eTMF for the country and site level.
  4. Site Support: Prepare and distribute Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs) or other files needed for Site Initiation Visits (SIVs). Prepare and maintain QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation to site visits and paperwork after site visits.
  5. Query Resolution and Metrics: Assist CRAs/Clinical Trial Lead with query resolution and aged action item metrics follow-up internally.
  6. Translation and Verification: Perform translations, back-translations or verification of translations of study documentation when needed.
  7. CTMS and Study Trackers: Accurately update and maintain site level CTMS, as needed. Prepare and maintain country and sites related study trackers, as needed.
  8. Administrative Support: Provide administrative tasks to support Office Managers and Country Managers, as required. Perform any other ad hoc administrative tasks not listed above to support team members with clinical trial execution, as required at Country/Site level.
Requirements

To be successful in this role, you will need to have excellent organizational and communication skills, with the ability to work independently and as part of a team. You will also need to have a strong attention to detail and be able to maintain confidentiality and discretion when handling sensitive information.

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