Caribou Biosciences, Inc. is a leading company in CRISPR genome engineering located in Berkeley, CA. Caribou's tools and technologies provide transformative capabilities to therapeutic development and the company is advancing an internal pipeline of gene-edited cell therapies for various oncology indications. The seven-year-old company has developed a best-in-class CRISPR genome engineering technology platform and has a leading intellectual property position.
Caribou Biosciences is seeking an experienced Senior Manager of Clinical Operations to help establish Caribou as a clinical stage company. The ideal candidate will direct and manage clinical CRO relationships and interact closely with senior management, regulatory, process development, functional group leaders, scientists, and research associates to implement clinical trials for multiple pre-clinical programs. This hands-on role will include documenting and reporting the clinical development program, negotiating contracts with CROs, study sites, clinical trial vendors as well as managing the recruitment, execution, and completion of clinical trials. The candidate must travel for site training, monitoring, etc. for approximately 30% of their working hours.
Responsibilities will include:
- Assist in developing study protocols, informed consents, study manuals, case report forms, clinical reports, and clinical SOPs
- Train and assist site coordinators, investigators, and CRO, and serve as a resource to site coordinators and investigators, monitor and track progress, and respond to day-to-day issues
- Perform site monitoring visits and interface with site coordinators, field clinical staff, and CROs
- Provide leadership to the overall strategic planning and successful implementation of the Company’s clinical development program
- Manage timelines for achieving clinical milestones
- Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
- Review study records to ensure regulatory and study requirements meet expectations
- Analyze data, interpret research information, create detailed documentation, develop tracking tools, and organize data for accurate clinical reports
- Create monitoring plans, coordinate study reports, and assist in developing sections for Investigator Brochures and clinical sections of other regulatory documents
- Assist in identification and hiring of CROs and other third-party vendors. Oversee performance of CRO and third-party vendors including co-monitoring to ensure compliance with study protocols
- Prepare, negotiate, and manage study budget. Perform initial review of CRO and vendor invoices
- Develop and implement enrollment strategies
- Compile and maintain regular status reports of study progress and study specific timelines
Candidate must possess:
- Bachelor’s degree or higher in a scientific or health care discipline
- At least 8 years in the role of Clinical Research Associate or Manager of Clinical Operations
- Minimum of 5 years in clinical operations including successful management of CROs and study sites from study start-up through study maintenance and close out, with demonstrated understanding of the data management components needed in a trial, enrollment objectives, management, and strategies
- Extensive experience in the preparation, monitoring, and execution of clinical studies
- Demonstrated ability to motivate clinical site personnel to achieve clinical operational milestones
- Excellent understanding and application of Good Clinical Practices (GCP) and ICH guidelines. Compliance with safety standards and privacy and confidentiality.
- Demonstrated medical/therapeutic knowledge and medical terminology
- Excellent verbal/written communication skills and organizational aptitude along with strong attention to detail
- Ability to work both independently and collaboratively with cross-functional teams and external organizations
- Critical thinking to analyze problems which may require multiple factors and approaches
- Practical knowledge of hospital or clinic operations
- Advanced degree in scientific research, medicine, or nursing
- Experience in oncology and/or cell-based therapies
- Project management skills
Caribou Biosciences, Inc. is a dynamic start-up company, and the successful candidate must have the ability and desire to work in a fast-paced environment. For more information, please visit www.cariboubio.com. Caribou is on Twitter. Sign up to follow our Twitter feed @CaribouBio.
Caribou offers a comprehensive compensation package, as well as generous paid time off in addition to Company-observed holidays. The Company provides medical, dental, and vision insurance, along with a 401(k) retirement savings plan which includes matching employer contributions. Caribou promotes a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork.
Caribou is an equal opportunity employer and does not discriminate on the basis of 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, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the basis listed above or any other characteristics protected under federal, state, or local laws.
Direct applicants only. No agencies please.