Senior Clinical Research Associate - Belgium

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Bedrijfsinformatie

  • PRA 
  • Mechelen, BE-VAN 

Omschrijving

GENERAL SUMMARY:The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH‐GCP, and all applicable regulatory requirements.ACCOUNTABILITIES:1. Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable localregulatory requirements and ICH‐GCP guidelines2. Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the properconduct of clinical trials, and close clinical trials at investigative sites3. Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely4. Provides regular site status information to team members, trial management, and updates trial management tools5. Completes monitoring activity documents as required by PRA SOPs or other contractual obligations6. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues7. Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed8. Performs essential document site file reconciliation9. Performs source document verification and query resolution10. Assesses IP accountability, dispensation, and compliance at the investigative sites11. Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH‐GCP guidelines12. Communicates with investigative sites13. Updates applicable tracking systems14. Ensures all required training is completed and documented15. Serves as observation visit leader16. Facilitates audit s and audit resolution17. Mentors junior level CRAs and serves as a resource for new employees18. Serves as observation and performance visit leader19. May be assigned additional Clinical Operations tasks20. May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines21. May be assigned clinical tasks where advanced negotiating skills are required

Vast contract, onbepaalde tijd uur per week

Vereisten


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Vacatureinformatie

  • Techniek  
  • 26-02-2014 
  • Full time baan  
  • in overleg, afhankelijk van kennis en ervaring 

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