Clinical Research Associate (Level Ii)

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Summarized Purpose**:
**Essential Functions**:
- 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 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 regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, tha...