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Senior Cra - Oncology - Fl

5+ years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 Clinical Research Associate (CRA) – Oncology


Location:

Miami, Florida (Remote-based)


Job ID:

2025-117236


Department:

Clinical Monitoring – ICON Strategic Solutions


Job Type:

Full-Time, Remote


Application Contact:

Name: Brandon Pupek
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Job Description:

As a Senior CRA (Oncology), you will serve as the primary contact for clinical trial sites, ensuring high-quality data collection and protocol compliance for early- and late-phase oncology trials. This remote role is based in Florida with regional travel requirements.


Key Responsibilities:

  • Act as primary liaison for assigned trial sites

  • Build strong site relationships and support site activation

  • Participate in feasibility assessments, pre-trial visits, and investigator meetings

  • Lead Clinical Site Management (CSM) activities for site setup, monitoring, and closure

  • Implement risk-based monitoring and resolve site issues proactively

  • Ensure regulatory compliance with ICH-GCP and protocol requirements

  • Verify data accuracy, completeness, and timely entry into systems

  • Ensure AE/SAE reporting, drug accountability, and site training

  • Conduct monitoring visits, write reports, and maintain essential documents

  • Collaborate on Corrective Action Preventive Action (CAPA) plans

  • May oversee up to 10 sites across 2–4 protocols depending on complexity


Required Qualifications:

  • BA/BS degree in a life sciences field

  • Minimum 5 years of clinical monitoring or site management experience

  • At least 2 years of experience in Oncology, Ophthalmology, Gene Therapy, or other relevant areas

  • Proficient in GCP, local regulatory standards, and protocol procedures

  • Strong problem-solving, communication, and IT skills

  • Willingness to travel up to 40% with overnight stays

  • Fluent in English; additional local language proficiency may be required


Preferred Qualifications:

  • Experience in cross-functional and matrix teams

  • Prior Lead CSM experience

  • Mentorship or training experience

  • Familiarity with early-phase trials


Benefits at ICON:

  • Competitive salary and annual leave

  • Health insurance for you and your family

  • Retirement planning support

  • Global Employee Assistance (TELUS Health)

  • Life assurance

  • Optional perks (varies by country): childcare vouchers, gym memberships, travel subsidies, etc.
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Inclusion & Accessibility:

ICON champions diversity and accessibility.
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