kariusdx - Karius - Sr. Clinical Research Associate

• Independently plan, conduct, and document on-site and remote monitoring visits, including site qualification visits (SQVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and closeout visits (COVs), in accordance with the Clinical Monitoring Plan, study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements. • Conduct comprehensive source data verification (SDV) and source data review (SDR) to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documentation and the study protocol. • Independently manage day-to-day site relationships, driving enrollment momentum, query resolution, protocol compliance, timely completion of study activities, and overall site performance. • Proactively identify, assess, and document monitoring findings, site-level risks, protocol deviations, compliance concerns, and data trends, and escalate significant or recurring issues with recommended corrective actions. • Prepare and submit timely, high-quality monitoring visit reports and follow-up correspondence that clearly document site health, compliance status, findings, risks, required actions, and follow-up expectations. • Track monitoring findings and action items through resolution and verify completion and effectiveness during subsequent monitoring contacts. • Oversee the collection, review, and maintenance of essential regulatory and study documents to support ongoing inspection readiness. • Support and lead site-level study start-up activities, including site qualification, readiness assessments, SIVs, regulatory document collection, and site activation requirements. • Support and lead site-level closeout activities, including COVs, resolution of outstanding queries and monitoring findings, reconciliation activities, and completion of required site documentation. • Collaborate closely with Clinical Trial Managers and cross-functional partners to provide site-level monitoring insights, risk assessments, and recommendations that inform study planning and operational decision-making. • Mentor junior CRAs and CTAs on monitoring standards, visit preparation and execution, documentation practices, site management, and issue resolution. • Monitor subject safety throughout the study, including timely review and assessment of adverse events (AEs) and serious adverse events (SAEs), and promptly escalate safety signals or reporting concerns in accordance with sponsor and regulatory requirements. • Develop, track, and confirm implementation of corrective and preventive action plans (CAPAs) with investigative sites following protocol deviations, compliance concerns, or recurring performance issues, and verify effectiveness during subsequent monitoring visits. • Evaluate and maintain Investigator Site Files (ISFs) and Trial Master File (TMF) documentation in accordance with sponsor SOPs, the TMF Reference Model, and study requirements, proactively identifying and resolving documentation gaps. • Facilitate and support site staff training and retraining on protocol requirements, eClinical systems, specimen collection and handling, and study-specific procedures throughout study conduct. • What’s Fun About the Job?Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.