CRA II

PRA HEALTH SCIENCES; United States; Remote; USD 65,000 - 85,000; Full time

Job summary

A leading clinical research organization is seeking a CRA II to manage clinical studies, ensuring compliance with protocols and regulatory standards. This role requires onsite monitoring, stakeholder engagement, and the ability to navigate complex research environments, with generous benefits and a commitment to diversity and inclusion.

Benefits

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Various annual leave entitlements

Flexible optional benefits

Qualifications

• 18+ months experience monitoring clinical studies with independent completion of monitoring activities.
• Onsite monitoring experience required.
• Experience in the Medical Device industry preferred.

Responsibilities

• Responsible for monitoring clinical research studies from inception to close-out.
• Ensures site staff are trained to the protocol and maintains study/data integrity.
• Creates monitoring reports and follow-up documentation.

Skills

Monitoring clinical studies

Stakeholder management

Regulatory compliance (GCP)

Training and qualification

Education

BS/BA in Scientific or relevant discipline

5 years' experience in Clinical Research

Job description

Overview

As a CRA II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• The Clinical Operations Clinical Research Associate (CRA) is responsible for monitoring of clinical research studies involving human subjects from its inception to close-out according to budget and timelines.
• Ensures that assigned site staff are appropriately trained to the study protocol and to ensure study and data integrity in support of a broader Clinical Evidence Strategy.
• Produces work abiding by applicable Regulatory statutes (such as GCP) and withstanding scrutiny in the event of an audit.
• Actively interfaces with various internal and external stakeholders including Clinical and Medical Affairs Management and functional teams, internal customers, Regulatory, Legal, CRO/vendor staff, and clinical research staff.
• Qualifies, Selects, Trains and Monitors internal and external study Investigators and study documentation.
• Responsible for creating monitoring reports and follow-up documentation and ensuring completion of updates in CTMS.

Qualifications

You are:

• BS/BA in Scientific or relevant discipline OR 5 years' experience in Clinical Research
• 18+ months experience monitoring clinical studies including independent completion of qualification, training, initiation, interim, and close-out monitoring activities
• Must have onsite monitoring experience
• Must be willing to travel 50% of the time
• Experience in the Medical Device industry is preferred
• Open to receive guidance and be mentored by more senior staff

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 maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt 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, colour, 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.