Job Title: Senior CRA
Company: ICON Strategic Solutions
Location: Poland (Home-Based)
Start Date: 17 April 2025
Closing Date: 17 May 2025
Job Overview:
Join ICON Strategic Solutions, the world’s largest and most comprehensive clinical research organisation, as a Senior Clinical Research Associate (CRA). This role involves full-cycle site management and monitoring responsibilities for clinical trials, with an emphasis on data integrity, patient safety, and regulatory compliance.
Key Responsibilities:
Serve as primary site contact and manager throughout all clinical trial phases
Develop and maintain strong site relationships from study initiation to closure
Conduct on-site and remote monitoring to ensure protocol, ICH-GCP, and regulatory compliance
Gain deep understanding of study protocols and procedures
Support site readiness and selection activities
Coordinate site visits: initiation, monitoring, validation, and close-out visits
Accurately document all site communications and monitoring activities
Monitor regulatory documentation for study start-up, maintenance, and closure
Communicate with investigators and site staff regarding all protocol and compliance-related matters
Collaborate with cross-functional teams including GCTO, regulatory, legal, finance, and vendors
Maintain records in CTMS, eTMF, and other clinical systems
Support or lead audit and inspection activities
Conduct co-monitoring and provide mentorship when required
Candidate Requirements:
Bachelor’s degree (preferred focus in science or biology)
Minimum 3 years of direct clinical monitoring experience
Experience with oncology trials or willingness to monitor in oncology
Fluent in Polish and English (verbal and written)
In-depth knowledge of GCP/ICH, clinical trial phases, and local clinical research regulations
Ability to mentor or lead monitoring activities
Strong proficiency in clinical documentation and IT tools (MS Office, clinical IT systems)
Proven ability in independent site management and patient recruitment strategies
Skilled in root cause analysis, with a solution-oriented mindset
Comfortable working with data metrics and performing site motivational visits
ICON Offers:
Competitive salary and country-specific benefits
Various annual leave entitlements
Customizable health insurance plans
Robust retirement savings plans
24/7 access to TELUS Health – Global Employee Assistance Programme
Life assurance and optional benefits like childcare vouchers, gym discounts, and more
Strong emphasis on diversity, inclusion, and workplace accessibility
Learn more about benefits and opportunities at ICON: ICON Careers
Request workplace accommodation: Reasonable Accommodations
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