Job Description
KPS is looking for Oversight Monitor to join sponsor team. Small FTE approx 0.2 for this year.
Responsibilities
- contributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan.
- contributes to the definition of appropriate standards and quality indicators for site management and monitoring.
- ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards.
- addresses issues identified with study conduct, monitoring and site management with Sponsor’s management, are appropriately communicated/escalated and follows up through resolution.
- May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed. ...