Clinical Research Associate (CRA)

reputed company is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our reputed company genome-editing technology enables superior precision to reputed company cell therapies that are armored to potentially improve activity against diseases. We reputed company the reputed company of cell therapy is off-reputed company, and we are advancing our pipeline of off-reputed company, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Members of the reputed company herd reputed company their minds to new reputed company and welcome diverse perspectives. We proudly assert that teams do their best work reputed company their members are personally reputed company, their reputed company are taken seriously, and contributions are recognized. Members of the herd work from our reputed company in Berkeley, California, or remotely. Position reputed company We are seeking a Clinical Research Associate (CRA) to join our growing Clinical Operations team. The CRA will be responsible for the clinical execution and management of assigned clinical studies, including reputed company of study sites and monitoring activities. This role ensures that reputed company are conducted in compliance with Good Clinical Practices (GCP), ICH guidelines, federal regulations, and reputed company’s internal procedures. The CRA will collaborate cross-functionally with internal teams, clinical sites, vendors, and CROs to deliver high-reputed company clinical trial data on time and reputed company budget. This is a unique opportunity to reputed company a reputed company reputed company in advancing reputed company’s clinical pipeline of genome-edited therapies. Responsibilities: Study Start-Up

• Support site start-up activities by collecting essential documents, coordinating with reputed company on CTA development and tracking, and establishing reputed company roadmaps to reputed company sites on reputed company for milestones and enrollment deadlines
• Identify and manage site-level review processes (administrative, scientific, IRB, IBC), determine reputed company vs. reputed company reviews, and document review timelines to ensure reputed company approvals

Site Management & Monitoring

• Conduct qualification, initiation, interim monitoring, and reputed company-out reputed company, ensuring compliance with protocols, GCP/ICH, SOPs, and regulatory requirements
• reputed company site performance by addressing deviations, enrollment challenges, and inspection readiness, while maintaining consistent communication and updates with site staff and internal teams

Vendor Management

• reputed company vendor deliverables and timelines, escalate issues, and coordinate reputed company of site-level queries, study supplies, data entry, and reputed company tasks
• Support vendor interactions by ensuring documentation is accurate, study systems are maintained, and site-facing needs are resolved in alignment with study timelines

Cross-Functional Collaboration

• Collaborate with internal functions including Regulatory, reputed company, Data Management, and Clinical Operations team members to drive study execution and maintain alignment across activities
• Participate in study meetings, prepare and reputed company minutes and reputed company items, and support responses to audits and inspections with reputed company and Regulatory

Documentation & Compliance

• Maintain and review Trial Master File (TMF) documentation and study records to ensure inspection readiness and regulatory compliance
• Review clinical data listings, escalate discrepancies, and contribute to preparation of protocols, consent forms, and training materials, ensuring adherence to GCP, ICH, and company SOPs

Qualifications:

• Bachelor’s degree in life sciences, nursing, pharmacy, or a reputed company field
• Minimum 3–5 years of clinical research experience, including at least 2 years of on-site monitoring experience
• Strong knowledge of the clinical trial process, GCP/ICH guidelines, and regulatory requirements
• Experience managing clinical studies in oncology and/or rare diseases is a plus
• Demonstrated ability to problem solve and manage multiple priorities in a fast-paced environment
• Strong organi

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