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Regulatory Data Coordinator

  1. Mexico City
JR118130
  1. ICON Full Service & Corporate Support
  2. Regulatory Affairs
  3. Office Based

About the role

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Regulatory Data Coordinator

JR118130

Site: Mexico

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 organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touchpoint. 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.

Overview:

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.


The role:

• 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 !RB 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.

You will need:

• knowledge of regulatory data management

Research Exp: 1 or 2 years

Bachelor’s degree in relevant field of study

Advanced English to Read, write, and speak



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.

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The Role of Regulatory Affairs in Clinical Research

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Industry

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Blogs

Publish date

01/18/2024

Summary

Introduction to Regulatory Affairs in Clinical Research Regulatory affairs play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices. In the

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Explore the pivotal role of regulatory affairs in clinical research with our insightful blog.

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