CRA (Level II)

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Job Description**

+ Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure andcorrective/preventiveactions 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.
+ Brings up observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
+ May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, tha...