Sr CRA

Standard (Mon-Fri)

Office

• Madrid (Hybrid basis)

• Barcelona (remote basis)

Position: Sr CRA (Level I and II)

• Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV andCRF 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, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator