What are the responsibilities and job description for the CRA II - In-Vitro Diagnostics position at Pharmaceutical Research Associates, Inc?
Overview
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.
Responsibilities
What you will be doing:
We're hiring a CRA to lead and support clinical research studies for in vitro diagnostics. This role involves study planning, monitoring, and execution while ensuring compliance with protocols and regulatory standards.
Conducting and documenting clinical studies per GCP, FDA, and IVD guidelines
Leading site selection, initiation, monitoring, and closeout
Validating product performance and supporting regulatory submissions
Gathering feedback from labs and key opinion leaders
Collaborating cross-functionally on post-launch activities
Qualifications
You Are:
5 years as a CRA; IVD experience preferred
Bachelor’s degree in a relevant field (Medical Technology or R&D background a plus)
CRA certification is a plus
Strong communication, organizational, and leadership skills
Ability to work independently and solve problems
Proficient in Microsoft Word, Excel; basic stats knowledge
Leadership or supervisory experience preferred
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, 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.
