Bayside Solutions · 4 hours ago
Clinical Research Associate Contractor
San Mateo County, CA
Contract
Onsite
Mid, Senior Level
$114K/yr - $135K/yr
5+ years expBayside Solutions is seeking a Clinical Research Associate Contractor to oversee all aspects of clinical trials from initiation to completion. The role includes ensuring compliance with regulations, managing study budgets and timelines, and tracking clinical trial progress while providing regular updates to management.
Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality
No H1B
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
Qualification
Required
A BS/MS degree (science-based) is required in a scientific or healthcare discipline
5+ years of relevant experience including 2+ years with clinical trial management
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
Preferred
Experience in neurodegeneration clinical trials (Alzheimer's, Parkinson's, ALS), or rare disease clinical trials preferred
Start-up biotech experience and hands-on experience with early phase studies (Phase 1 & 2) would be beneficial
Company
Bayside Solutions
Bayside Solutions is a staffing and recruiting company offering IT, telecom, and scientific staffing services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
B
Bob Klotz
Founder
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