Clinical Research Associate (Start-Up) – Oncology | Illinois
Location: Downers Grove (Greater Chicago Area)
Job Reference: JR144442
Company: ICON plc
Division: ICON Strategic Solutions
Department: Clinical Monitoring – Study Start-Up
Work Model: Remote (Illinois-Based, Travel Required)
Job Overview
ICON Strategic Solutions is seeking a Clinical Research Associate (Start-Up) – Oncology to support oncology clinical trial site activation and regulatory start-up activities across Illinois. This role focuses on accelerating site selection, regulatory approvals, and investigator activation to ensure timely study launch within oncology programs.
The CRA (Start-Up) will collaborate with country operations teams, investigators, and sponsors to drive efficient study initiation while maintaining full compliance with ICH-GCP and US regulatory requirements.
This opportunity is ideal for oncology CRAs with start-up expertise who are seeking growth within a global CRO environment.
Key Responsibilities
Manage oncology clinical trial start-up activities across multiple protocols
Conduct Site Qualification Visits (SQVs) to assess site feasibility and eligibility
Identify, select, and activate clinical trial sites aligned with study timelines
Coordinate collection of essential regulatory documents, contracts, and approvals
Serve as primary point of contact for sites during the start-up phase
Monitor and report key performance indicators (KPIs) related to site activation timelines
Ensure compliance with ICH-GCP, FDA regulations, and sponsor SOPs
Proactively identify and mitigate start-up risks or delays
Maintain inspection-ready documentation and audit preparedness
Support sites through activation until “Green Light” status is achieved
Assist with audit and inspection preparation as required
Required Experience
Minimum 2–3 years of monitoring experience within the pharmaceutical or CRO industry
At least 1–3 years of oncology clinical trial experience required
Hands-on experience in study start-up, site activation, and regulatory document collection
Strong understanding of ICH-GCP, FDA regulations, and US clinical trial requirements
Experience using CTMS, EDC, eTMF, IWRS, safety reporting systems, and trial dashboards
Analytical or risk-based monitoring experience preferred
Educational Qualifications
Bachelor of Science degree in Biological Sciences, Life Sciences, or related field preferred
Registered Nurse (RN) qualification may be considered
Eligibility & Travel Requirements
Must reside in Illinois, preferably near a major airport for regional travel
Willingness to travel as required for site qualification and activation visits
Must be legally authorized to work in the United States without visa sponsorship
Core Competencies
Strong oncology start-up and site activation expertise
Excellent stakeholder management and communication skills
Ability to drive patient recruitment strategies at the site level
Strong organizational and documentation management skills
Self-motivated with the ability to work independently and collaboratively
Why Join ICON plc?
ICON plc is a leading global clinical research organization delivering outsourced development and commercialization services to pharmaceutical, biotechnology, and medical device companies worldwide. ICON supports full-service clinical development, from start-up and monitoring through regulatory submission and post-marketing studies.
Employees benefit from:
Competitive compensation structure
Comprehensive health insurance plans
Retirement savings and long-term planning programs
Annual leave entitlements
Global Employee Assistance Programme (LifeWorks)
Life assurance coverage
Flexible, country-specific employee benefits
ICON is committed to fostering an inclusive and compliant workplace, offering equal employment opportunities and career advancement within the clinical research industry.
Apply now through ThePharmaDaily.com to advance your oncology clinical research career in study start-up and site activation management.
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