Clinical Research Associate (Start-Up) – Oncology
Location: Los Angeles, California, United States (Remote-Based)
Job ID: JR143254
Employment Type: Full-Time
Work Model: Remote (Candidate must reside in the Los Angeles area near a major airport)
Role Overview
An established global clinical research organization is seeking a Clinical Research Associate (CRA) – Start-Up, Oncology to support early-phase and cross-therapeutic clinical trial start-up activities across the United States.
This remote-based role focuses on site identification, qualification, regulatory coordination, and activation within oncology studies. The CRA will play a critical role in accelerating site readiness while ensuring full compliance with ICH-GCP, regulatory standards, and sponsor timelines.
Candidates must be based in Los Angeles, CA, with convenient access to a major airport to support regional travel as needed.
Key Responsibilities
Site Start-Up & Activation
Manage multiple oncology and cross-therapeutic clinical trials with a primary focus on start-up activities
Collaborate with country operations teams to identify, select, and activate investigational sites according to study timelines
Conduct Site Qualification Visits (SQVs) to evaluate site capabilities and feasibility
Serve as the primary point of contact for sites, internal study teams, and external stakeholders during start-up
Coordinate collection of essential regulatory documents, contracts, and approvals to support timely activation
Support sites through activation until “Green Light” status is achieved
Regulatory & Compliance Oversight
Ensure adherence to ICH-GCP, local regulatory requirements, and internal SOPs
Maintain inspection-ready documentation in CTMS, eTMF, and other trial management systems
Assist with audit and regulatory inspection preparation as required
Track, analyze, and report key performance indicators (KPIs) related to site selection and activation timelines
Operational Excellence
Proactively identify and mitigate risks that could delay study initiation
Partner closely with investigators and site staff to meet activation milestones
Support patient recruitment strategy discussions at site level
Utilize clinical systems including CTMS, EDC, eTMF, IWRS, and safety reporting platforms
Provide regular status updates to stakeholders to ensure milestone alignment
Required Qualifications
Bachelor of Science (B.S.), Registered Nurse (RN), or equivalent degree, preferably in Biological or Life Sciences
Minimum 2–3 years of experience monitoring pharmaceutical industry clinical trials
1–3 years of direct oncology clinical trial monitoring experience (mandatory)
Strong knowledge of ICH-GCP guidelines and U.S. regulatory requirements
Experience using clinical trial systems such as CTMS, EDC, eTMF, IWRS, and reporting dashboards
Strong analytical and risk-based monitoring capabilities (preferred)
Excellent communication, negotiation, and stakeholder management skills
Ability to work independently in a remote environment
Must reside in Los Angeles, CA, near a major airport
Legal authorization to work in the United States without visa sponsorship
Preferred Competencies
Experience managing site contracts, budgets, and regulatory submissions during start-up
Demonstrated ability to accelerate site activation timelines
Strong collaboration skills within matrixed clinical operations teams
Why Consider This Opportunity
This role offers the opportunity to contribute to oncology clinical trial activation and early study execution within a dynamic CRO environment. As a Start-Up CRA specializing in oncology, you will directly impact site readiness, regulatory compliance, and study launch timelines for innovative cancer therapies.
SEO & GEO Keywords: Clinical Research Associate Start-Up Jobs USA, Oncology CRA Jobs Los Angeles CA, Clinical Trial Start-Up Specialist California, Oncology Monitoring Careers United States, Remote CRA Oncology Jobs, ICH-GCP Clinical Research Roles, Site Activation Specialist Oncology
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