Responsible for implementation of clinical trial protocols and ensuring these protocols are conducted according to FDA regulations.
Compile and maintain regulatory documents.
Coordinat, organized and maintained all study documentation including source documentation, case report forms, study and regulatory binders and patient binders.
Screened subjects from our clinic database and confirm eligibility of potential study subjects.
Collection of lab samples, process samples and prepaired for shipment under the IATA guidelines.
Prepared and processed all documentation through the Institutional Review Board (IRB), including submissions, continuing reviews, amendments and adverse event reporting.
Prepared for and participated in audits conducted by sponsors.
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