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Kossir KHALID

Villejuif

En résumé

Experience in conducting clinical research protocols in phase II and III according to Good Clinical Practice and national and international regulatory standards.
- Coordination on Clinical Trial in Oncology.
- Development of tools for patient support,
- Filling paper and electronic CRF,
- Carrying out of Activities related to Pharmacovigilance (SUSAR and SAE)
- Communication with Sponsor / CRO

Mes compétences :
Clinical Research

Entreprises

  • Institut Gustave Roussy - Clinical Resarch Coordinator

    Villejuif 2011 - maintenant
    *Oversee clinical operations related to conduct of the trial (i.e. recruitment, informed consent, procedure, visit coordination, sampling, visit scheduling, etc)
    *Work in collaboration with study team to ensure trial preparedness
    *Attend investigator’s meetings, study project meetings, and other meetings as needed
    *Serve as point person for monitoring needs. Prepare monitoring visits to ensure monitors receive all necessary information during their visits
    *Organize and participate in the site initiation visit
    *Review protocol with the clinical team and ensure clinical team is familiarized with their roles and responsibilities
    *Develop reporting mechanism for bringing critical and high priority issues to the investigator, study sponsors, and/or the monitors
    *Develop and implement an internal system for quality assurance
    *Play a role in developing and implementing a recruitment plan to ensure long-term recruitment target is met
    *Monitor enrollment and provide enrollment updates for the clinical team and the sponsors
    *With assistance from the sponsors and in collaboration with the investigator and site staff, develop site-specific protocol documents and the informed consent document
    *Oversee/Manage timely and accurate transcription of information on source documents, paper case report forms (CRFs), as well as electronic CRFs
    *Participate in data query resolution process
    *Maintain updated Investigator’s file, including regulatory documents
    *Maintain communication with IRB and take lead in reporting adverse events, protocol deviations, safety reports, and other items as directed by ICH guidelines and the IRBs
    *Develop standard operation procedures (SOPs) in collaboration with sponsor and site investigator
    *Ensure consistent and appropriate compliance to the Standard Operating Procedures
    *Ensure proper documentation specifications are in place during the conduct of the trial

Formations

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