CRA II - Medical Device - Cardio

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

What you will be doing:

The role of the Clinical Research Associate II is to ensure execution of clinical studies is conducted according to applicable requirements, regulations, and guidance.

• Provide leadership in execution of clinical studies to deliver high quality data to support sponsor on time, within budget and in compliance to all applicable regulations and sponsor procedures
• Drive adoption of compliant clinical study execution practices through sponsor active in clinical studies including research and testing of products involving human beings
• Develop and maintain the policies and procedures for the Clinical Operations function of Clinical and Medical Affairs.
• Support, update and maintain the Clinical Trial Management System application for clinical study execution and reporting
• 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.

You are:

• 5+ years' experience in Clinical Research (Preferred BS/BA in Scientific or relevant discipline)
• 2+ years' 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 25% of the time
• Experience in the Medical Device industry is preferred, preferably Cardiovascular
• Open to receive guidance and be mentored by more senior staff
• Preferred previous experience as a Site Coordinator
• Must have Site Management experience

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/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested 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.