Clinical Research Associate II

IRE • Orlando, FL

4d

About The Position

The Clinical Research Associate II works in a sponsor-dedicated model at ICON Strategic Solutions, serving as the primary point of contact between investigational sites and the sponsor. The role supports clinical studies across multiple therapeutic areas and includes site monitoring, compliance oversight, documentation, patient safety reporting, and collaboration with cross-functional clinical teams. The role is based in Orlando, Florida, and requires travel for on-site monitoring visits across the Southeast region.

Requirements

• Bachelor’s degree in Life Sciences or equivalent, or qualification as an 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 across multiple therapeutic areas.
• Proficiency in ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.
• Clear communication, problem-solving, and collaborative teamwork skills.
• Willingness and ability to travel up to 60%–75% for on-site monitoring visits across the Southeast region.

Nice To Haves

• Preference for candidates residing in Orlando, Florida, near major hub airports to support efficient regional travel.

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 applicable regulations.
• Maintain current documentation in CTMS and eTMF systems.
• Support and track site staff training and maintain compliance records.
• Monitor patient safety and ensure timely, accurate AE/SAE/PQC reporting.
• Support site-level subject recruitment and retention efforts.
• Oversee drug accountability and ensure proper storage, return, or destruction.
• Resolve data queries and promote timely, high-quality data entry.
• Document site progress and escalate risks or issues to the clinical team.
• Assist with 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.
• Medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes 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