Contribute to all clinical research activities to ensure the successful start-up and management of
Maintain and track clinical study data monitored and help in Investigator, Sub-Investigators
Co-Management of site start-up/activation process, including heavy contribution to the preparation
Assist with eCRFs/EDC system, CTMS, eTMF and imaging Core Labs
Assist with review of IRB submissions, consents and applicable regulatory documentation with
Assist with amendments clinical study documents (ICF, CRFs, protocols, Monitoring Plan, study

🎯 Requirements

Previous experience implementing pharmaceutical trials
Significant knowledge of clinical and/or outcomes research study design
Experience with surgical trials is preferred
Possess advanced knowledge of Clinical investigation of investigational drugs for human subjects
Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations
Fundamental knowledge of clinical research and monitoring requirements

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