Clinical Research Associate (CRA)

ICON plc • Blue Bell, SD

3d

About The Position

The Clinical Research Associate (CRA) will work in a sponsor-dedicated model at ICON Strategic Solutions, supported by ICON’s global expertise. The role focuses on early development across multiple therapeutic areas in the United States and contributes to the development of treatments for patients worldwide. The CRA serves as the main contact between investigational sites and the sponsor, monitors site conduct and compliance, supports patient safety and data quality, and collaborates with clinical team partners.

Requirements

• Bachelor’s degree in Life Sciences or equivalent, or be a qualified RN.
• Eligible to work in the United States without visa sponsorship.
• At least 2 years of on-site monitoring experience in the pharmaceutical or CRO industry.
• Experience monitoring Phase I/II clinical trials.
• Proficiency in ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.
• Clear communication, problem-solving, and collaborative teamwork skills.

Responsibilities

• Serve as the primary point of contact between investigational sites and the sponsor.
• Conduct site selection, initiation, routine monitoring, and close-out visits.
• Ensure site compliance with ICH-GCP, SOPs, and regulations.
• Maintain up-to-date documentation in CTMS and eTMF systems.
• Support and track site staff training and maintain compliance records.
• Monitor patient safety and ensure timely and accurate AE/SAE/PQC reporting.
• Support subject recruitment and retention efforts at the site level.
• Oversee drug accountability and ensure proper storage, return, or destruction.
• Resolve data queries and drive timely, high-quality data entry.
• Document site progress and escalate risks or issues to the clinical team.
• Assist in tracking site budgets and ensuring timely site payments, as applicable.
• Collaborate with cross-functional partners, including CTAs, LTMs, and CTMs.

Benefits

• Competitive base salary and performance-related incentives.
• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programs and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level