Senior Clinical Research Associate

1 semana atrás


Manaus, Brasil Bebeeclinicalresearch Tempo inteiro

Job OverviewClinical research associates play a pivotal role in the design, analysis, and interpretation of clinical trials.They contribute to the advancement of innovative treatments and therapies.Conduct onsite and remote monitoring activities according to ICH-GCP guidelines, applicable regulations, and study processes.Verify the protection of study participants by confirming informed consent procedures and protocol adherence to applicable regulations.Ensure the integrity of clinical data and compliance with approved protocols, GCP, applicable regulations, and SOPs.Key ResponsibilitiesManage essential documents as required by local regulations and ICH-GCP guidelines; assist with resolution of investigational site/data queries.Perform key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.Participate in audit preparation and follow-up activities as needed.RequirementsUndergraduate degree or international equivalent in a clinical, scientific, or healthcare-related field from an accredited institution; health care professional licensure (e.g., registered nurse).Previous experience supporting clinical trials, including solid onsite monitoring experience in CROs or pharmaceutical companies.



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