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 antitumor activity. 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 and CAR-NK platforms as readily available treatments for patients with hematologic malignancies and solid tumors.
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.
We are seeking a Senior Clinical Trial Specialist to join our growing Clinical Operations group. You will be responsible for assisting the Clinical Operations Project Leadership Directors. The Senior Clinical Trial Specialist reports to the Executive Director of Clinical Operations. This position will be remote.
The Senior Clinical Trial Specialist works on moderately complex clinical trial activities in support of the Clinical Operations Project Leadership Directors. You will work closely with the clinical operations team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The Senior Clinical Trial Specialist may assist with service provider oversight and management. You will identify issues in a timely manner and escalate to management as appropriate, will support Clinical Operations in ensuring the financial health of assigned clinical studies, and will oversee study milestones.
Responsibilities:
Support activities related to all phases of clinical studies including: study/site feasibility, start-up, maintenance, and close-out
Manage and oversee study- and site-essential documents review, collection, and tracking
Support the initiation, preparation, and maintenance of core study documents (Informed Consent Forms, study plans, site and patient materials, training and guidance documents, and pharmacy-, clinical supply- and laboratory-related documents)
Oversee Study Trial Master File (TMF)
Ensure required study documents are received, reviewed and filed in the TMF in accordance with GCP and applicable regulations
Organize and prepare study-related meetings (agenda, minutes, slides, etc.)
Prepare, oversee and maintain study logs (risk, issue, decision logs, etc.)
Support and participate in departmental, study team, and service provider meetings
Attend study related meetings
Participate in study related collaborative process efforts and reviews (protocol development, service provider selection, departmental initiatives, etc.)
Complete monitoring visit report reviews and performs co-monitoring or monitoring oversight visits
Support, tracks, and triages site and service provider queries
Support rapid action to address both internal and site QA findings from audits
Manage, coordinate, and oversee the activities from third party service providers including timelines, contract deliverables, metrics, accruals, process planning, and implementation
Track and maintain studies, including but not limited to study status, enrollment, deviations, documents, and plans
Support oversight of clinical site performance, metrics, and monitoring visits
Assist and supports study data related activities including data review, query creation and resolution, study and protocol deviation reviews, and safety reviews
Work cross-functionally with direction from Clinical Operations
Review and verifies service provider activities
Support study reporting and tracking with applicable systems and technology
Support study lead in cross-functional alignment of study timelines
Support study lead in financial management of service providers (e.g., contract and invoice reconciliation)
Qualifications:
Bachelor's degree or equivalent work experience
3-5 years relevant work experience
Able to demonstrate proficiency in technology use, documentation practices, business practices, version control management, and document control
Advanced proficiency in Microsoft 365 suite, including Word, Excel, PowerPoint, Outlook, and SharePoint
Strong attention to detail and a commitment to producing high-quality work
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Caribou compensation and benefits include:
Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Salary Range: $115,000 - $150,000. 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 and floating 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, 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.
No salary data published by company so we estimated salary based on similar jobs related to Microsoft and Senior jobs that are similar:
$60,000 — $100,000/year
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