Senior Clinical Research Associate (Sr. CRA) – Remote | Chicago, IL / Missouri
Company: ICON plc
Job Type: Full-Time
Work Model: Remote (Field-Based)
Location: Chicago, Illinois and Missouri, United States
Experience Required: Minimum 5–8+ Years of Clinical Research Associate Experience
Travel Requirement: Up to 60% (Domestic and/or International)
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies in delivering innovative therapies to market. ICON provides full-service clinical development solutions across all phases of clinical trials, ensuring quality, compliance, and operational excellence worldwide.
Job Overview
ICON is seeking a Senior Clinical Research Associate (Sr. CRA) to oversee site monitoring activities and ensure clinical trials are conducted in compliance with study protocols, regulatory standards, and Good Clinical Practice (GCP) guidelines.
This remote, field-based role is ideal for experienced CRAs who have demonstrated expertise in site management, data integrity oversight, regulatory compliance, and multi-site coordination across complex clinical studies.
The Senior CRA will play a key leadership role in ensuring participant safety, accurate data collection, and high-performing investigational sites throughout the clinical trial lifecycle.
Key Responsibilities
Site Monitoring and Compliance Oversight
Conduct qualification, initiation, routine monitoring, and close-out visits.
Ensure compliance with ICH-GCP, FDA regulations, and protocol requirements.
Verify data accuracy, source documentation, and investigational product accountability.
Site Performance Management
Evaluate site performance metrics and implement corrective action plans as needed.
Identify protocol deviations and ensure timely resolution.
Provide ongoing operational support to investigational sites.
Data Integrity and Reporting
Ensure timely and accurate data entry into EDC systems.
Review case report forms (CRFs) and source documentation for completeness and consistency.
Collaborate with data management and clinical operations teams to address data queries.
Cross-Functional Collaboration
Work closely with Clinical Trial Managers, Project Managers, and Regulatory teams.
Participate in sponsor meetings and internal strategy discussions.
Support inspection readiness and audit preparation activities.
Training and Mentorship
Provide guidance and training to site staff and junior CRAs.
Promote adherence to monitoring best practices and quality standards.
Required Qualifications and Experience
Advanced degree in Life Sciences, Nursing, Pharmacy, Medicine, or related discipline.
Minimum 5–8+ years of experience as a Clinical Research Associate within a CRO, pharmaceutical, or biotech organization.
Strong knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements.
Demonstrated experience managing multiple sites and complex clinical studies simultaneously.
Proficiency in EDC systems, CTMS platforms, and clinical trial documentation processes.
Excellent organizational, analytical, and problem-solving skills.
Strong communication and stakeholder management capabilities.
Ability to travel up to 60% and maintain a valid driver’s license.
Preferred Competencies
Experience in multi-regional or global clinical trials.
Therapeutic area expertise in oncology, CNS, cardiology, or rare diseases.
Audit and inspection support experience.
Experience mentoring junior CRAs or leading monitoring strategies.
Compensation and Benefits
ICON offers competitive compensation aligned with market standards, along with a comprehensive benefits package that may include:
Paid annual leave
Health and medical insurance plans
Retirement savings programs
Life assurance
Employee Assistance Programs
Flexible, country-specific benefits
ICON is committed to maintaining a diverse and inclusive workplace and provides equal employment opportunities to all qualified applicants.
Who Should Apply
This position is ideal for:
Senior Clinical Research Associates
Lead CRAs
Field-Based Clinical Monitors
Site Management Professionals
Clinical Operations Specialists
If you are an experienced CRA seeking a leadership-focused monitoring role within a global CRO environment, this opportunity offers strategic exposure to complex clinical development programs.
For more global clinical research, pharmacovigilance, regulatory affairs, and CRO job opportunities, visit ThePharmaDaily.com.
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