Marlene Gonzalez
- Role
- Regulatory Coordinator Ii at Dana-Farber Cancer Institute
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
Experience
Regulatory Coordinator Ii
Aug 2016 — Present
Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.\\\\nPrepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc.\\\\nPrepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, DF/HCC sponsored etc.\\\\nMaintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.\\\\nAssists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC QACT, Industry Sponsors, and third party auditors.\\\\n\\\\n
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