Clinical Regulatory Affairs Expert
2 weeks ago
Position Overview
Regulatory Affairs Specialist - Clinical Research
Schedule: Full-time; Day shift 8:00 AM to 5:00 PM PST (Monday to Friday)
This role involves the preparation, facilitation, coordination, and submission of essential documentation required by federal, state, and local regulations, as well as institutional standards related to research activities. Responsibilities include the meticulous preparation of all submissions to the Institutional Review Board (IRB) to ensure the safeguarding of human subjects involved in research. Additionally, the role encompasses the completion of FDA-required submissions, which may involve investigator 1572 forms, investigational new drug applications, and device submissions, including Emergency Use and Humanitarian Device Exemptions (HDE), along with Safety Reports and other pertinent documents mandated by regulatory bodies or the institution.
The position may require leading the efforts of Research Assistants on a task-oriented basis, providing on-the-job training, establishing priorities, and scheduling workflows to meet project objectives effectively.
Qualifications Required:
- Bachelor's Degree in a relevant field such as science or healthcare, or significant experience in research coordination or regulatory affairs may be considered in lieu of educational requirements.
- A minimum of 2 years of experience in a healthcare, research, or clinical environment with a solid understanding of regulatory compliance.
Why Choose This Opportunity?
We offer a comprehensive benefits package designed to support your health, professional growth, and financial security. Our commitment to your well-being allows you to focus on our mission of enhancing the health and wellness of each patient.
About the Organization
Our organization is dedicated to the principle of 'Know me, care for me, ease my way.' Working within our network means that every role contributes to our mission, with robust support for your career development. We pride ourselves on providing exceptional benefits and fostering an inclusive environment where diversity is celebrated, and every individual is valued and respected.
Commitment to Diversity and Inclusion
We are committed to creating a diverse workforce and promoting an inclusive workplace where all employees can thrive. Our recruitment practices prioritize diversity in all forms, ensuring equal opportunities for advancement.
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