Kariusdx The Sr. Clinical Research Associate independently manages and monitors clinical sites ensuring compliance with protocols and regulatory requirements. The role involves applying risk-based monitoring and conducting source data verification.
Responsibilities
Independently plan, conduct, and document on-site and remote monitoring visits including SQVs, SIVs, IMVs, and COVs
Apply a risk-based monitoring approach to evaluate site performance, protocol compliance, data quality, subject safety, and documentation completeness
Conduct comprehensive source data verification (SDV) and source data review (SDR) to ensure CRF data accuracy and consistency