Clinical Study Coordinator

hace 1 semana

Centro, España Mabxience A tiempo completo

Overview:
At MabXience, ensure the seamless execution and oversight of clinical trials under your responsibility, delegated to CROs. Guarantee that all trials are conducted within the established timelines and quality standards.

Responsibilities:

  1. Manage the clinical trial plan , communicate any timeline deviations to the Medical Director, and participate in creating contingency plans and corrective measures.
  2. Select and oversee CROs and external vendors , ensuring all activities are executed according to plan (cost, quality, and time).
  3. Collaborate with study partners and the Medical Director to identify centers and researchers, ensuring trial performance criteria are met.
  4. Review necessary documentation to obtain approvals from CEICs and Health Authorities.
  5. Create and update the monitoring plan for the study.
  6. Review and approve all trial materials and guidelines .
  7. Supervise IMP control , including distribution, handling, stock management, and destruction.
  8. Oversee blood sample control for pharmacokinetic/pharmacodynamic studies, ensuring timely shipment for analysis and storage.
  9. Inform and update researchers on all relevant aspects of the clinical trials.
  10. Ensure the quality of participating centers in the monitored studies.
  11. Participate in forming and coordinating Independent Committees (IDMC, IRC, etc.), maintaining documentation traceability.
  12. Prepare materials for initial visits to supervised centers.
  13. Draft and coordinate protocol amendments , ensuring new versions are edited as needed.
  14. Review trial documentation (monitoring reports, teleconference minutes, etc.) to ensure alignment with plans.
  15. Maintain communication with potential partners , providing monthly updates and organizing kick-off meetings.
  16. Create and maintain files for CROs and mAbxience centers , organizing study file transfers and final quality control.
  17. Conduct co-selection, monitoring, and closing visits as required, and perform monitoring tasks if assigned.
  18. Organize and participate in researcher meetings for the clinical trial.
  19. Create and maintain a tracking system for CRO activities, country-specific activities, recruitment, and vendor management.
  20. Participate in audits .
  21. Ensure compliance with company procedures, Good Clinical Practices, and applicable legislation for all clinical trials under your responsibility.

Qualifications:

  1. Education: Degree in Health Sciences; a Master’s degree is a plus.
  2. Languages: Fluent in Spanish and English; additional languages are an asset.
  3. Experience: Over 4 years in a similar role, managing international clinical trials.
  4. Specific Knowledge: Must have knowledge of applicable laws in international clinical trials.
  5. Travel: Willingness to travel.
  6. Personal Skills:
    • Strong organizational and prioritization skills
    • Detail-oriented
    • Proficient in database and literature searches
    • Excellent interpersonal skills and effective in a team environment
    • Clear and effective written and verbal communication skills
    • Ability to work under pressure and meet tight deadlines
    • Client-focused approach to work
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