Clinical Trial Specialist

Location

Berkeley, CA | United States

Job description

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 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.

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Job tags

Salary

$60k - $100k