Clinical Regulatory Affairs Coordinator
2 weeks ago
Position Overview
Clinical Regulatory Affairs Coordinator - Research Division
Schedule: Full-time; Day shift 8:00 AM to 5:00 PM PST (Monday to Friday)
The Clinical Regulatory Affairs Coordinator is responsible for the preparation, facilitation, coordination, and submission of essential documentation required by various regulatory bodies and institutional guidelines pertinent to research activities. This role encompasses the meticulous preparation of submissions to the Institutional Review Board (IRB) to ensure the safeguarding of human subjects involved in research, as well as compliance with FDA requirements, which may include forms such as the investigator 1572, investigational new drug applications, and device submissions, among others. Additionally, this position may involve leading the efforts of Research Assistants on a task-oriented basis, providing necessary training, setting priorities, and organizing workflow to meet project goals.
Key Qualifications:
- A Bachelor’s Degree in a relevant field such as science or healthcare, or equivalent experience in research coordination or regulatory affairs.
- A minimum of 2 years of experience in a healthcare, research, or clinical environment with a solid understanding of regulatory compliance.
Why Join Providence?
At Providence, we offer a comprehensive benefits package designed to support your health, professional growth, and financial stability. We prioritize your well-being, allowing you to focus on our mission of enhancing the health and wellness of every patient we serve.
About Providence
Our commitment to our Promise of "Know me, care for me, ease my way" drives our work at Providence. We are dedicated to fostering an inclusive environment where diversity is celebrated, and every team member is valued and respected. With over 120,000 caregivers across multiple locations, we are committed to serving our communities and advancing healthcare practices.
Equal Opportunity Employer
Providence is proud to be an Equal Opportunity Employer, committed to creating a workplace free from discrimination and harassment. We believe that diversity strengthens our organization and are dedicated to providing equal opportunities for all employees.
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