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Clinical Research Associate Ii- Nebraska

2+ 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:

Clinical Research Associate II (CRA II)


Location:

Nebraska, United States (Remote)


Job ID:

2025-117742


Department:

Clinical Monitoring – ICON Strategic Solutions


Job Type:

Full-Time, Remote


Application Contact:

Name: Melissa Benner
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Job Description:

As a CRA II, you will perform on-site and remote monitoring activities, ensuring that clinical trials comply with ICH-GCP guidelines, applicable regulations, and study protocols. You will manage investigative site staff to achieve trial objectives, such as subject enrollment and data accuracy, while maintaining strong communication and adherence to regulatory requirements.


Key Responsibilities:

  • Perform on-site and remote monitoring activities in compliance with ICH-GCP, SOPs, and study protocols

  • Ensure participant protection, informed consent procedures, and protocol adherence

  • Manage and monitor investigational product (IP) accountability

  • Verify the integrity of clinical data and escalate deficiencies as necessary

  • Manage essential study documents in accordance with regulations

  • Perform risk assessments and monitor site health

  • Participate in audits and follow-up activities

  • Mentor less experienced team members

  • Independently manage assigned monitoring visits


Requirements:

  • Education:

    • Undergraduate degree in clinical, science, or health-related field

    • Healthcare professional licensure (e.g., Registered Nurse) is desirable

  • Experience:

    • 2+ years of experience in clinical trials, including at least 2 years of on-site monitoring experience

    • In-depth knowledge of ICH-GCP and applicable regulatory requirements

    • Strong interpersonal, communication, and organizational skills

    • Ability to travel extensively and establish effective site relationships

    • Proficiency with Microsoft Office, clinical systems, and company collaboration tools


Benefits:

  • Competitive salary and annual leave

  • Health insurance options for you and your family

  • Retirement planning with strong savings benefits

  • Global Employee Assistance Program (TELUS Health)

  • Life assurance

  • Country-specific optional benefits (childcare vouchers, gym memberships, etc.)
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Inclusion & Accessibility:

ICON fosters an inclusive environment and provides equal employment opportunities regardless of race, color, religion, gender, or disability.
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