**Work Schedule**



Standard (Mon-Fri)



**Environmental Conditions**



Office



**Job Description**



Monitors investigator sites with a risk-based monitoring approach: applies root

Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site

processes failure and corrective/preventive actions to bring the site into

compliance and decrease risks. Ensures data accuracy through SDR, SDV and

CRF review as applicable through on-site and remote monitoring activities.

Assess investigational product through physical inventory and records review.

Documents observations in reports and letters in a timely manner using

approved business writing standards. Escalates observed deficiencies and issues

to clinical management expeditiously and follow all issues through to resolution.

May need to maintain r...