CRA (Level II)

**Job Description**

Summarized Purpose:

Performs and coordinates all aspects of the clinical monitoring and site management process in accordance 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. Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites. Generally required to travel 60-80% but more for some individuals.

Essential Functions and Other Job Information:

Essential Functions · 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 a timely manner using approve...