Regulatory Data Coordinator
hace 4 semanas
Job Summary
This role 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.
Key Responsibilities
- 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.
- 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.
Requirements
- Knowledge of regulatory data management.
- Research experience: 1 or 2 years.
- Bachelor's degree in relevant field of study.
- Advanced English to Read, write, and speak.
Benefits of Working at 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, regular benchmarking against competitors, and annual bonuses reflecting delivery of performance goals. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.
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