Regulatory Data Coordinator

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center 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.

This position is responsible for the completion of all initial IRB submissions and maintenance of regulatory documents for all clinical trials. The Regulatory Data Coordinator will work closely with Medical Director, Project Manager, Clinical Research Coordinators and Manager, Clinical Data Services to ensure the timely and accurate submission of regulatory documents to the IRB.

• Recognize, exemplify and adhere to ICON's values which center on our commitment to People, Clients and Performance.
• As a member of staff, the employee is 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.
• Travel (approximately 0%) domestic and/or international
• Primary liaison between the investigative site, sponsor and Institutional Review Boards (IRBs).
• Responsible for providing updates to appropriate personnel regarding all IRB related issues.
• Ensures adherence to timelines related to regulatory submissions.
• Assures all IRB submissions are in compliance with all relevant IRB and FDA requirements.
• Ensures all regulatory documents are updated and filed appropriately.
• Participates in internal and external audits as required.
• Follows any reasonable directive from the Medical Director, Principal Investigator and Manager, Clinical Data Services.
• To undertake other reasonably related duties as may be assigned from time to time.


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.