Job description
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 organizational, interpersonal, and communication skills
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams) and clinical trial management systems
- Ability to travel up to 30–50%, depending on study needs
- Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
- Ability to work independently on multiple projects internally and with external vendors
- Possess a sense of urgency; identify challenges and problems and take the initiative to identify solutions
Caribou compensation and benefits include:
- Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
- Salary Range: $115,000 - $135,000. This represents the present low and high end of the Company’s pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance
- Generous paid vacation time, in addition to company-observed holidays
- Excellent medical, dental, and vision insurance
- 401(k) retirement savings plan, which includes matching employer contributions
- Employee stock purchase plan (ESPP)
- Tuition reimbursement program
The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, hair texture or type or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.
