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Senior Cra

3+ years
Not Disclosed
10 April 29, 2025
Job Description
Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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