Senior Clinical Research Associate

📋 Description

• • Drive the success of Orca Bio’s breakthrough cell-therapy portfolio by owning full-cycle clinical monitoring for the pivotal Phase 3 PRECISION-T trial and several early-phase studies, ensuring every protocol amendment, data point, and safety narrative is captured with the precision that one million blood-cancer patients are counting on.
• • Plan, schedule, and execute weekly interim monitoring visits—both on-site and remote—at premier academic transplant centers and community hospitals across North America, traveling to one site per week when virtual oversight is insufficient and coordinating seamless follow-up remotely to keep studies on critical path and within budget.
• • Perform rigorous source-data verification (SDV) by cross-referencing EMR/EHR entries against eCRF data, identifying discrepancies, coaching site staff on Good Documentation Practices, and escalating protocol deviations or GCP non-compliance in real time to protect data integrity and patient safety.
• • 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 safety signals and regulatory submissions.
• • Serve as the primary liaison for principal investigators, research coordinators, and sub-investigators, providing hands-on support for query resolution, protocol training, and best-practice sharing that elevates site performance and enhances the patient experience.
• • Collaborate with Data Management, Clinical Operations, Biostatistics, and Regulatory Affairs to drive data lock timelines and inspection readiness, ensuring every dataset can withstand FDA, EMA, and PMDA scrutiny.
• • 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.
• • 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.