Clinical Research Associate
TFS HealthScience
Google Cloud PlatformTFS
Clinical Research Associate, CRA
Caribou Biosciences
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $115,000 - $135,000 per year
Job Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- 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
- 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
- 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
- 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
- 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
Requirements
- 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
- Legal authorization to work in the United States is required
