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Regulatory Affairs Coordinator
2 months ago
Company: Kaiser Permanente
Job Overview:
In this role, you will be responsible for overseeing and managing all regulatory functions associated with clinical research within the Clinical Research Support Services Department. Your primary focus will be to ensure compliance with governmental regulations through a robust quality management system.
Key Responsibilities:
- Facilitate precise quality data collection and the interpretation of research protocols for regulatory compliance.
- Prepare and submit regulatory documentation to the Institutional Review Board, including requests for new research protocols, safety reports, and adverse event documentation.
- Engage with study sponsors and team members to resolve scientific and ethical concerns.
- Design and implement systems that cater to departmental and regulatory requirements.
- Assist in assessing processes for optimal resource utilization.
Essential Qualifications:
Experience: At least 1 year in a clinical research environment.
Education: Bachelor’s degree in a scientific discipline or 4 years of relevant experience.
Additional Qualifications:
- Proficient in Microsoft Word and Excel.
- Excellent written and verbal communication abilities.
- Capability to perform well under pressure and collaborate across various departments.
- Familiarity with medical terminology.
Preferred Qualifications:
- Minimum of 2 years in a clinical research setting.
- 2 years of experience in research and data abstraction.
- Comprehensive understanding of FDA regulations and medical terminology.
- Proficiency in MS Office and database management.
About Kaiser Permanente:
Kaiser Permanente is dedicated to fostering diversity and inclusion within its workforce, providing a supportive and enriching work environment. As an equal opportunity employer, Kaiser Permanente is committed to creating an inclusive atmosphere for all employees, regardless of their backgrounds.
