03
Jun
2018

Clinical Research Associate Vivaldi 24-155F – Manila

PPD Asia Pacific – Metro Manila – Clinical Research Associate Vivaldi 24-155F – Manila PPD Asia Pacific – Manila, Metro Manila Job Description – Clinical Research Associate Vivaldi 24-155F – Manila (146485) Summarized Purpose: Performs and coordinates all aspects of the clinical monitoring and site management process in conformity with ICH GCP, FDA guidelines, local regulations and PPD SOPs. Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Ensures that data will pass international quality assurance audits. Develops collaborative relationships with investigational sites. Generally required to travel 60-80% but more for some individuals. Essential Functions and Other Job Information: Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification). Assess investigational product through physical inventory and records review. Documents observations in reports and letters in …

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