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 Trial Assistant (CTA) to join our growing Clinical Operations team. The CTA will provide critical support to the clinical trial team to ensure the smooth and efficient execution of Caribou’s clinical studies. This role is responsible for managing study documentation, tracking trial activities, and coordinating operational tasks in compliance with Good Clinical Practices (GCP), ICH guidelines, and Caribou’s internal procedures.
The CTA will collaborate closely with the Clinical Operations and other cross-functional teams, vendors, and study sites to maintain accurate records, support study milestones, and help ensure inspection readiness. This is an excellent opportunity to gain hands-on experience in clinical research and contribute to Caribou’s mission of advancing transformative therapies.
Responsibilities:
Study Start-Up
- Support the collection, review, and tracking of essential site start-up documents
- Assist with the preparation, distribution, and maintenance of site study materials and binders
- Help track regulatory and ethics committee submissions and approvals
Site Management & Monitoring
- Maintain study trackers for site information, enrollment status, and essential documents
- Assist with scheduling and coordinating site visits, meetings, and teleconferences
- Aid in the distribution and collection of legal documents such as confidentiality agreements, clinical trial agreements, master service agreements, statements of work, etc
- Track and file monitoring visit reports and correspondence to ensure inspection readiness
Vendor Management
- Support coordination with vendors by tracking deliverables, filing documentation, and ensuring study systems are updated
- Assist with site supply logistics, ensuring timely distribution and reconciliation of study materials
Cross-Functional Collaboration
- Collaborate with Clinical Operations, Data Management, Regulatory, and cross functional teams to maintain study documentation and timelines
- Support study team meetings by preparing agendas, distributing materials, and drafting minutes
Documentation & Compliance
- Maintain and update the Trial Master File (TMF) and ensure timely filing of essential documents
- Track and reconcile study documentation, ensuring alignment with GCP, ICH guidelines, and SOPs
- Assist with audit and inspection readiness activities by ensuring documentation is complete, accurate, and accessible
Qualifications:
- Bachelor’s degree in life sciences, health sciences, or a related field preferred; equivalent work experience considered
- 1+ year(s) of sponsor experience in Clinical Operations
- Strong organizational skills with keen attention to detail and accuracy
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and experience with clinical trial systems is a plus
- Excellent communication and interpersonal skills with the ability to work effectively in a team environment
- Ability to manage multiple tasks and prioritize in a fast-paced setting
- 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 15%
- Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
- 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: $95,000 - $105,000. 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.
