Clinical Research Associate Contractor

Clinical Research Associate Contractor

W2 Contract

Salary Range: $114,400 - $135,200 per year

Location: South San Francisco, CA - Onsite Role

Job Summary:

The Clinical Research Associate role involves overseeing all aspects of clinical trials from initiation to completion, ensuring compliance with SOPs, FDA regulations, and ICH/GCP guidelines. The individual is responsible for preparing and managing study budgets, timelines, and vendor performance, while also tracking clinical trial progress and providing regular status updates to management. Key duties include managing clinical trial vendors, reviewing study-related documents, assessing patient enrollment feasibility, and contributing to study strategy development. The role also involves identifying and mitigating program risks, participating in site selection and monitoring activities, and ensuring adherence to regulatory and protocol requirements for successful trial execution.

Duties and Responsibilities:

• Oversee clinical trials from initiation to completion, ensuring compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
• Prepare and manage study budgets, timelines, and vendor performance to meet departmental and corporate goals.
• Monitor and track clinical trial progress, providing regular status updates and metrics to management.
• Manage clinical trial vendors, including CROs, central labs, and imaging, ensuring adherence to contracted scope, timelines, and budgets.
• Participate in the development and review of key study-related documents, including Monitoring Plans, Laboratory Manuals, and Patient Diaries.
• Assess the feasibility of patient enrollment and contribute to strategy development, including RFIs, RFPs, and bid defense meetings.
• Provide input on study strategy, protocol development, informed consent forms, CRFs, and clinical study reports.
• Identify and mitigate program risks, developing strategies to ensure successful trial execution.
• Participate in site selection, initiation, and monitoring activities, ensuring adherence to protocol and regulatory requirements.

Requirements and Qualifications:

• A BS/MS degree (science-based) is required in a scientific or healthcare discipline, experience in neurodegeneration clinical trials (Alzheimer's, Parkinson's, ALS), or rare disease clinical trials preferred
• 5+ years of relevant experience including 2+ years with clinical trial management
• Start-up biotech experience and hands-on experience with early phase studies (Phase 1 & 2) would be beneficial.
• Working knowledge of FDA regulations and ICH GCP guidelines is required.
• Proven ability to implement and manage a clinical program
• Strong analytical and strategic agility skills
• Highly effective team player with exceptional interpersonal skills

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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