Lead CRA
- United States
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
About the role
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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
- Applies knowledge of ICON’s policies and procedures
- Demonstrates excellent written and oral communication
- Demonstrates excellent knowledge of ICH/GCP
- Displays ability to manage investigative sites to facilitate trial deliverables
- Demonstrates ability to escalate issues appropriately
- Conducts monitoring to confirm subject safety and data integrity
- Describes and demonstrates the principals of IP accountability
- Identifies scientific misconduct at the site level
- Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
- Mentors CRAs new to the position or company
- Serves as an observation visit leader
- Conducts monitoring evaluation visits
- Assists team lead in the development of trial tools or documents
- Assists with CTM tasks
- Participates in the development of process changes/improvements
- Presents at client meetings/Investigator meetings
- Provides training to trial teams
Qualifications:
- Bachelors degree
- Read, write and speak fluent English; fluent in host country language required.
- 4+ years of experience supporting clinical trials. No In-House or site level experience will be considered
- Ability to travel - our sponsors allow low and regional travel. Travel frequency will be disucssed during the screening phase.
- Proven success monitoring fast paced trials with quick turnaround times for database lock
- High proficiency with Microsoft Office and company collaboration applications
- Advanced skill in utilization of applicable clinical systems
- Experience in monitoring all trial components (PSSV to COV) is 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
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 or submit a request here.
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
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