Quality And Regulatory Compliance Associate Fully Remote
Corrona
Remote
regulatory
regulatory compliance
compliance
remote
regulatory
compliance
regulatory compliance
items
employee training
training
tracking
team
excel
November 22, 2022
Corrona
Waltham, Massachusetts
- Quality and Regulatory Compliance Associate Fully Remote Position
- As a Quality and Regulatory Compliance Associate you will work collaboratively across departments to support the Quality and Regulatory Compliance department in ensuring CorEvitas compliance with regulations, IRB and sponsor obligations, and ethical standards for research while maintaining consistency and quality across regulatory, site-, and patient-facing materials.
- Preparing and filing all IRB site submissions for North American Registries
- Verifying completeness of site master files
- Performing document control - including versioning, filing, and archiving - of controlled study documents and Standard Operating Procedures
- Attending audits to document responses and record action items
- Maintaining the Employee Training Matrix (a record of all controlled documents for the Clinical Registry business unit)
- Receiving, tracking, and documenting completion of employee training
- Support Quality & Regulatory Compliance Team in all quality or regulatory matters
- Attending team meetings; taking notes and tracking departmental action items
- Excellent verbal and written communication skills
- Proven ability to manage multiple projects simultaneously, without losing track of details
- Strong working knowledge of MS Office, Word, PowerPoint and Excel
- Additional Experience and Qualifications
- Bachelors Degree and/ or 2+ years of administrative experience preferred
- Bachelors degree required
- Advanced knowledge of Microsoft Project, Excel, PowerPoint, Word required
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