Clinical Research Associate
ClinTec International
Total des années d'expérience :15 years, 11 Mois
Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout
Responsible for the safety and proper conduct throughout the trial
Verifying that the investigator follows the approved protocol and all GCP procedures
Verifying that source data/documents and other trial records are accurate, complete, and maintained
Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs
Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator
provide regulatory submission assistance to company on mainly HMC and Supreme Council of Health.
Provide regulatory assistance on Oman Ministry of Health.
Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout
Responsible for the safety and proper conduct throughout the trial
Verifying that the investigator follows the approved protocol and all GCP procedures
Verifying that source data/documents and other trial records are accurate, complete, and maintained
Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs
Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator