Principal CRA

ICON Strategic Solutions; United States; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Competitive retirement planning

Global Employee Assistance Programme

Job summary

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.

As a Principal CRA at ICON, you will oversee and manage clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare field.
• Extensive experience as a Clinical Research Associate in pharma/biotech/CRO with a track record of managing complex trials.
• In-depth knowledge of ICH-GCP guidelines and regulatory processes.
• Strong leadership and mentoring skills to guide CRAs and site staff.

Responsibilities

• Lead site management activities from site selection to close-out visits, ensuring protocol and regulatory compliance.
• Serve as primary contact for clinical sites, addressing queries and sustaining site engagement and performance.
• Ensure data integrity through source data verification and monitoring for protocol deviations.
• Mentor CRAs and promote best practices across studies.
• Collaborate with cross-functional teams to ensure successful trial execution.

Skills

Site management

Clinical trial monitoring

ICH-GCP knowledge

Leadership/mentoring

Communication & problem-solving

Travel readiness

Education

Bachelor's degree in life sciences or healthcare

Job description

Principal Clinical Research Associate

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.

As a Principal CRA at ICON, you will oversee and manage clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards.

What You Will Do

Your focus will be on coordinating clinical trial monitoring delivery, resolving issues, and developing team capability.

Key Responsibilities Include

• Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines.
• Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance.
• Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations.
• Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies.
• Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials.

Your Profile

You will have solid clinical trial monitoring experience, with the ability to manage competing priorities and develop your team.

Required Qualifications And Experience

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials.
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
• Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively.
• Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues.
• Willingness to travel as required (approximately 60%)

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here