Senior CRA

ICON plc

21h • Remote

About The Position

Senior Clinical Research Associate, Remote based in Northeast USA ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Clinical Research Associate (CRA) in the Northeast region to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. Ideal locations would be: Northern NJ, New York Metro or CT.

Requirements

• Bachelor’s degree (scientific field preferred)
• 3+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits
• Experience utilizing Veeva CTMS for report writing is required
• Demonstrated experience developing/maintaining site relationships and securing compliance
• Expertise in GCPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
• Experience collaborating with sites from initial engagement through close-out phases
• Experience activating sites
• Experience training site staff
• Experience supporting sites and/or sponsors in regulatory inspections
• Willing to travel up to 50% domestically
• Reside in Northeast Region USA

Nice To Haves

• 1+ years early development trial experience preferred
• Solid tumor clinical trial experience is preferred
• Experience working within an FSP (or in-house) monitoring model is preferred

Responsibilities

• Perform site management activities to support Oncology site success and maintain a continuous state of inspection readiness
• Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in trials
• Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
• Support sites during regulatory inspections
• Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
• Lead site engagement initiatives and foster relationships with key Oncology sites and networks

Benefits

• In addition to your competitive salary, ICON offers a range of additional benefits.
• Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees