US CRA II / Senior CRA
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.
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Job Responsibilities::
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People Clients and Performance.
• As a member of staff, the employee I expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• *Ability and willingness to travel at least 60% of the time (international and domestic: fly and drive)
• *Expert knowledge of ICON Clinical Research SOPs/WPs, ICH, GCP and appropriate regulations.
• *Expert knowledgeable of ICON systems.
• *Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
• Recruitment of investigators.
• *Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following:
Identify investigators.
Help, when requested, in preparation of regulatory submissions. Design patient information sheets and consent forms.
Co-ordinate documents translation, verification and back translations where required.
Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.
Pre Study/placement and initiation visits.
Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP, as appropriate
Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports.
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
Keep the project manager or designees regularly informed.
Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner.
Ensure the satisfactory close-out of investigator sites.
Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
Ensure correct archiving of files on completion of a study. Maintain patient and sponsor confidentiality.
Assume additional responsibilities as directed by Project Manager (PM)
Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a Project Manager.
Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.
Co-ordinate and/or participate in feasibility studies for new proposals, as required. lnvestigational Products (IPs) stored and managed by the site:
• Ensure storage conditions and acceptable supplies are provided
• Ensure IPs are supplied only to eligible patients
• Ensure IP receipt, use and return are controlled and documented
• Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
• *Be cost effective.
• *Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
• Participate in data listing reviews, as applicable.
• Assist with marketing the company if and when appropriate.
• Other duties as assigned.
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON 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, 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.
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, 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 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.
Are you a current ICON Employee? Please click here to apply
