Bayside Solutions · 10 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 involves ensuring compliance with SOPs, FDA regulations, and ICH/GCP guidelines while managing study budgets, timelines, and vendor performance.
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)
Experience in rare disease clinical trials
Start-up biotech experience
Hands-on experience with early phase studies (Phase 1 & 2)
Clinical trial oversight
Clinical trial management
ICH GCP compliance
FDA regulations
SOP compliance
Study start-up and close-out
Study budgets and timelines
Vendor management
CRO oversight
Central lab management
Imaging vendor management
Clinical trial metrics and reporting
Risk identification and mitigation
Study strategy development
Patient enrollment feasibility assessment
Site selection and initiation
Site monitoring
Protocol adherence
Regulatory compliance
Monitoring plans
Laboratory manuals
Patient diaries
Protocol development
Informed consent forms (ICFs)
Case report forms (CRFs)
Clinical study reports (CSRs)
RFI and RFP development
Bid defense participation
Early phase clinical studies (Phase I/II)
Neurodegeneration clinical trials
Rare disease clinical trials
Biotech start-up experience
Cross-functional collaboration
Analytical and strategic thinking
Program management
Stakeholder communication
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
Company data provided by crunchbase