Regulatory Affairs Specialist
2 days ago
We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at the University of California, Irvine. The successful candidate will be responsible for ensuring the successful management of the regulatory aspects of each study conducted through our Center for Clinical Research.
Key Responsibilities- Manage regulatory documents, including study protocols, guidance documents, and study manuals
- Submit IRB applications and work with study sponsors and monitors
- Ensure compliance with regulatory requirements and industry standards
- Collaborate with cross-functional teams to achieve study activation and enrollment targets
- Develop and implement process improvements to enhance study management and regulatory compliance
- Bachelor's degree in a related field or equivalent experience
- 2-3 years of experience in regulatory affairs, clinical research, or a related field
- CCRP certification through a national clinical research association (SOCRA or ACRP) or willingness to become certified
- Excellent communication, problem-solving, and interpersonal skills
- Ability to work in a fast-paced environment and prioritize multiple tasks and deadlines
- Experience with IND submissions and FDA inspections
- Knowledge of CTMS systems, preferably OnCore
- Familiarity with clinical research coordination and study management
In addition to a competitive salary, we offer a comprehensive benefits package, including medical insurance, sick and vacation time, retirement savings plans, and access to discounts and perks.
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. We are committed to attracting and retaining a diverse workforce and creating a welcoming and inclusive environment for all employees.
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