Senior Clinical Research Associate

�

� Description

• • Own end-to-end monitoring for Orca Bio’s flagship Phase 3 PRECISION-T trial and multiple early-phase studies, ensuring every data point, protocol deviation, and safety event is captured with the rigor that one million blood-cancer patients are counting on.
• • Plan and execute weekly interim monitoring visits (IMVs)—both on-site and virtual—across leading academic transplant centers and community hospitals, traveling to one site per week when virtual oversight is not permitted and coordinating follow-up remotely to keep studies on schedule and within budget.
• • Perform in-depth source-data verification (SDV) by cross-referencing electronic medical records (EMR/EHR) against eCRF entries, identifying discrepancies, coaching site staff on Good Documentation Practices, and escalating protocol deviations or GCP non-compliance in real time.
• • Review and verify adverse events, serious adverse events, concomitant medications, and underlying illnesses to ensure accurate, timely reporting that meets FDA, ICH-GCP, and internal SOP requirements—directly influencing patient-safety signals and regulatory submissions.
• • Serve as the primary point of contact for principal investigators, research coordinators, and sub-investigators, providing hands-on support for query resolution, training on protocol nuances, and best-practice sharing that elevates site performance and patient experience.
• • Contribute to the creation and refinement of trial-specific materials—CRFs, monitoring guidelines, site training toolkits, and risk-based monitoring plans—translating complex cell-therapy science into practical, user-friendly resources.
• • Partner with Data Management, Clinical Operations, Biostatistics, and Regulatory Affairs to drive data integrity, lock timelines, and inspection readiness, ensuring that every dataset can withstand FDA, EMA, and PMDA scrutiny.
• • Continuously improve Clinical Operations infrastructure by drafting and revising SOPs, work instructions, and templates, embedding quality-by-design principles that scale with Orca Bio’s rapid growth from late-stage start-up to commercial-stage biotech.
• • Leverage cutting-edge technology stacks—IBM Zelta EDC, Veeva Vault eTMF, CTMS, and diverse EMR platforms—to streamline workflows, reduce monitoring burden, and maximize time spent on high-value scientific engagement.
• • Champion a culture of curiosity, courage, and integrity by mentoring junior CRAs, sharing lessons learned across studies, and challenging the status quo with data-driven insights that accelerate the path to regulatory approval and patient access.