Clinical Research Associate

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� Description

• • Drive the success of our landmark Phase 3 PRECISION-T study as a Clinical Research Associate on a fully remote, contract basis. You will be the eyes and ears of Orca Bio in the field, ensuring that every data point, every protocol deviation, and every patient safety signal is captured with the highest scientific rigor. Your work directly underpins our mission to replace today’s high-risk stem-cell transplant with a next-generation, precision-purified cell therapy that could save the lives of more than one million Americans fighting blood cancers.
• • Plan, schedule, and execute interim monitoring visits (IMVs) for academic medical centers, community hospitals, and private practices across the United States—approximately one on-site visit per week for sites that do not allow virtual monitoring. Balance travel with remote activities to maximize efficiency and minimize site burden.
• • Perform in-depth Investigator Site File (ISF) reviews to confirm essential documents are present, current, and audit-ready. Identify gaps early and partner with site staff to close them before they become compliance risks.
• • Conduct source-data verification (SDV) by reviewing electronic medical records (EMR/EHR) and cross-checking entries against eCRF data in IBM Zelta. Flag discrepancies, coach coordinators on Good Documentation Practices, and ensure every protocol deviation is captured, categorized, and reported per SOPs and ICH-GCP.
• • Verify safety data integrity: review adverse events, serious adverse events, concomitant medications, and medical histories for completeness, accuracy, and consistency. Escalate safety findings to Clinical Operations and Pharmacovigilance teams within mandated timelines.
• • Serve as the primary point of contact for site personnel—principal investigators, research coordinators, pharmacists, and data managers—providing real-time guidance on protocol interpretation, enrollment strategy, and data query resolution. Build relationships that foster trust, transparency, and long-term partnership.
• • Contribute to the creation and refinement of study-specific tools: draft monitoring guidelines, site training slide decks, tip sheets, and FAQ documents. Translate complex regulatory language into practical, user-friendly resources that empower sites to deliver high-quality data.
• • Partner with Data Management, Biostatistics, and Regulatory Affairs to ensure seamless data flow from site to TMF to EDC. Participate in cross-functional working groups to improve CRF design, edit-check specifications, and data-review workflows.
• • Maintain Trial Master File (TMF) completeness in real time using the DIA reference model. Upload visit reports, monitoring letters, and follow-up trackers within 48 hours of activity completion, ensuring inspection readiness at all times.
• • Champion continuous improvement: identify bottlenecks in monitoring processes, propose data-driven solutions, and pilot new technologies (e.g., remote SDV, risk-based monitoring triggers) that can scale across our growing pipeline of cell-therapy trials.
• • Embrace Orca Bio’s entrepreneurial culture by wearing multiple hats—jump into ad-hoc tasks ranging from regulatory document QC to training new CRAs—while maintaining an unwavering focus on patient safety and data quality.
• • Uphold our core values of passion, courage, and integrity in every interaction. Whether you are debriefing a site PI on a serious adverse event or mentoring a junior CRA, you will model the highest ethical standards and inspire others to do the same.