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Janssen Pharmaceutica
- Attaché de Recherche Clinique (CRA II)
Beerse
2016 - maintenant
- Perform monitoring activities to meet SOP, GCP and Regulatory requirements.
- Conduct Monitoring Visits (MVs) according to the timelines requested and ensure that timelines are realized for Monitoring Visit Reports (MVRs). Also ensure timely management of the Monitoring Visit Follow Up letters in accordance metrics.
- Ensure timelines for data entry in RAVE are managed by investigators for all sites, according to the SOPs.
- Ensure that all essential systems are up-to-date and consistent for all sites
- Implement New Way of Working, including ARBM according to Monitoring Guidelines
- Ensure timely and high-quality implementation of the essential documents (ICF, ICF Amendments, Investigator Brochure, IB Amendments, Protocol, Protocol Amendments, Insurance Statement, Financial Agreement etc.) at the site level, during the conduct of the trial.
- Conduct high-quality Source Data Verification/Review (SDV/SDR), in line with the Monitoring Guidelines (MG).
- Report issue Escalation and Protocol Deviations
- Ensure adequate and compliant safety reporting (AEs and SAEs) according to the reporting timelines.
- Ensure Healthcare Compliance (HCC) requirement on the site level.
- Ensure that site staff is trained before starting with trial-related activities and during the trial, as necessary.
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PRA Health Sciences
- Attaché de Recherche Clinique (CRA I)
2015 - 2016
CRA I at Janssen Pharmaceutical Companies of Johnson & Johnson) With oncology speciality and study in Early Development (Phase 1-2a)
- Implements and monitors clinical trials
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
- Reviews and verifies accuracy of clinical trial data collected
- Provides regular site status information
- Completes monitoring activity documents as required by PRA SOPs
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
- Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
- Performs source document verification and query resolution
- Assesses IP accountability, dispensation, and compliance at the investigative sites
- Verifies Serious Adverse Event (SAE) reporting
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Janssen Pharmaceutica
- Attaché de Recherche Clinique
Beerse
2014 - 2015
Suivi d'étude phase I à IV : traduction de protocole, mise en place d'étude, visite de monitoring etc. Les études portent sur différentes pathologies (oncologie, infectiologie...)
Implication dans le Crédit Impôt Recherche de l'année 2014.
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Inserm
- Attaché de Recherche Clinique
PARIS 13
2014 - 2014
Mise en place d’une méthode de vérification du consentement à distance.
Suivi des études en cours : Réalisation de Mise en place, Monitoring et Clôture sur site.
