Regulatory Data Coordinator
- Mexico City
- ICON Full Service & Corporate Support
- Regulatory Affairs
- Office Based
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
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.
#LI-FB1
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 Learn more about Our Culture at ICON
Day in the life
Teaser label
IndustryContent type
BlogsPublish 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
Similar jobs at ICON
Salary
Location
India, Chennai
Department
Clinical Trial Management
Location
Bangalore
Chennai
Bengaluru
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Document Management
Job Type
Permanent
Description
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 I
Reference
JR117226
Expiry date
01/01/0001
Author
Amrutha SaidalaAuthor
Amrutha SaidalaSalary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
As a Global Regulatory Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-115379
Expiry date
01/01/0001
Salary
Location
India, Chennai
Department
Clinical Trial Management
Location
Chennai
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Document Management
Job Type
Permanent
Description
We are currently seeking a Senior Director, TMF Operations to join our diverse and dynamic team. As a Senior Director, TMF Operations at ICON, you will play a pivotal role in overseeing the management
Reference
JR126428
Expiry date
01/01/0001
Author
Lindsey EltzrothAuthor
Lindsey EltzrothSalary
Location
Mexico, Mexico City
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
Regulatory Data CoordinatorJR126472Site: Mexico (Office Based with Flex) : 3 days at office, and 2 days at homeWe are currently seeking a Regulatory Data Coordinator to join our diverse and dynamic te
Reference
JR126472
Expiry date
01/01/0001
Author
Fernanda BezerraAuthor
Fernanda BezerraSalary
Location
Korea, South
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
South Korea
Seoul
Business Area
ICON Strategic Solutions
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
(Sr.) Regulatory Affairs Specialist, Seoul, South Korea You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is
Reference
2024-115136
Expiry date
01/01/0001
Author
Sonia OhAuthor
Sonia OhSalary
Location
UK, Reading
Location
Sofia
Dublin
Limerick
Warsaw
Johannesburg
Barcelona
Madrid
London
Reading
Warwickshire
Swansea
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Director, Regulatory Operations to join our diverse and dynamic team. As a Director, Regulatory Operations at ICON, you will play a pivotal role in designing and analyzing c
Reference
JR124836
Expiry date
01/01/0001
Author
Hajni HowardAuthor
Hajni Howard