Clinical Research Associate (CRA)
Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, 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 Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.
Position Summary
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 oversight of study sites and monitoring activities. This role ensures that clinical trials are conducted in compliance with Good Clinical Practices (GCP), ICH guidelines, federal regulations, and Caribou’s internal procedures.
The CRA will collaborate cross-functionally with internal teams, clinical sites, vendors, and CROs to deliver high-quality clinical trial data on time and within budget. This is a unique opportunity to make a direct impact in advancing Caribou’s clinical pipeline of genome-edited therapies.
Responsibilities:
Study Start-Up
• Support site start-up activities by collecting essential documents, coordinating with Legal on CTA development and tracking, and establishing structured roadmaps to keep sites on target for milestones and enrollment deadlines
• Identify and manage site-level review processes (administrative, scientific, IRB, IBC), determine sequencing vs. parallel reviews, and document review timelines to ensure timely approvals
Site Management & Monitoring
• Conduct qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with protocols, GCP/ICH, SOPs, and regulatory requirements
• Oversee site performance by addressing deviations, enrollment challenges, and inspection readiness, while maintaining consistent communication and updates with site staff and internal teams
Vendor Management
• Track vendor deliverables and timelines, escalate issues, and coordinate resolution of site-level queries, study supplies, data entry, and related 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, Quality, Data Management, and Clinical Operations team members to drive study execution and maintain alignment across activities
• Participate in study meetings, prepare and track minutes and action items, and support responses to audits and inspections with Quality 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 related 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
Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.
Position Summary
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 oversight of study sites and monitoring activities. This role ensures that clinical trials are conducted in compliance with Good Clinical Practices (GCP), ICH guidelines, federal regulations, and Caribou’s internal procedures.
The CRA will collaborate cross-functionally with internal teams, clinical sites, vendors, and CROs to deliver high-quality clinical trial data on time and within budget. This is a unique opportunity to make a direct impact in advancing Caribou’s clinical pipeline of genome-edited therapies.
Responsibilities:
Study Start-Up
• Support site start-up activities by collecting essential documents, coordinating with Legal on CTA development and tracking, and establishing structured roadmaps to keep sites on target for milestones and enrollment deadlines
• Identify and manage site-level review processes (administrative, scientific, IRB, IBC), determine sequencing vs. parallel reviews, and document review timelines to ensure timely approvals
Site Management & Monitoring
• Conduct qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with protocols, GCP/ICH, SOPs, and regulatory requirements
• Oversee site performance by addressing deviations, enrollment challenges, and inspection readiness, while maintaining consistent communication and updates with site staff and internal teams
Vendor Management
• Track vendor deliverables and timelines, escalate issues, and coordinate resolution of site-level queries, study supplies, data entry, and related 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, Quality, Data Management, and Clinical Operations team members to drive study execution and maintain alignment across activities
• Participate in study meetings, prepare and track minutes and action items, and support responses to audits and inspections with Quality 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 related 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