FSP Clinical Research Associate II

Monitors investigator sites with a risk-based monitoring approach. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Documents observations in reports and letters in a timely manner and escalates observed deficiencies to clinical management. Conducts monitoring tasks in accordance with the approved monitoring plan and participates in the investigator payment process.

Bachelor's degree in a life sciences related field or a Registered Nursing certification. Previous experience comparable to 1 year as a clinical research monitor. Proven clinical monitoring skills and demonstrated understanding of ICH GCPs and applicable regulations.