Apprentice - Clinical Research
AbbVie
- Rungis, Val-de-Marne
- CDI
- Temps-plein
- Train to become knowledgeable of basic tasks in assigned area of responsibility. Demonstrates compliance with local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans and to quality standards in conducting clinical research.
- Learn and expand knowledge with the help of the certified/qualified CRA. Comprehend and apply all required technical, regulatory and safety trainings.
- Conduct all activities in a professional manner. Listen actively to acquire information and understand work procedures. Participate in the sharing of information to promote overall efficiency of the process. Attend and actively participate in meetings.
- Under supervision of a qualified CRA, help conducting on-site and off-site monitoring activities for Phase 1-4 studies to ensure successful execution of the protocol in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes. Ensure all required documentation is available and valid in the Investigator Site File.
- Under supervision of a qualified person, help prepare documentation for regulatory submission dossier or perform any other activities related to start-up phase.
- Assist the qualified CRA in preparing site investigator payments as per executed contract obligations.
- Ensure Trial Master File completeness and accuracy, upload essential documents and perform Quality Control reviews of the documentation.
- Ensure completeness and accuracy of the data entered into the Clinical Trial Management System (LBE/actual date, Company personal, site staff…) or any other database as needed.
- rigorous, organized, proactive, and able to juggle multiple tasks
- curious, open-minded, adaptable and enjoy working in a team environment