What are the responsibilities and job description for the Regulatory Specialist position at Medasource?
Summary :
The Regulatory Support Specialist, under director of the Clinical Trials Compliance Director, will provide regulatory support to the Northern California PI and research sites conducting multiple FDA-regulated or other clinical trials.
Responsibilities :
- Compliance Monitoring and Reporting with IRB Standard Operating Procedures and document applications
- Adhere to Guideline for GCP, federal, sate, and local regulations
- Assist with the preparation for internal and external inspections, audits and monitor visits
- Assist in assuring that all site documents, including SOPs and study regulatory files, are maintained in audit-ready condition
- Maintain communication with internal / external parties and research team regarding regulatory document matters
- Work with an assigned mentor on a regular basis for training and resource questions
- Attend Sponsor site initiation meetings
Requirements :
Soft Skills :
