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Regulatory Affairs Specialist
National Institutes of Health · Posted 1 days ago
About the Role
If you are an experienced Regulatory Affairs Specialist and you want to play a significant role in a dynamic organization, then consider joining the National Institutes of Health!
What You'll Do
- →Provide regulatory and protocol navigation support for assigned portfolio of clinical trials and Investigators.
- →Prepare and compile data from ongoing protocols and drafts annual continuing review reports for distribution to appropriate regulatory agencies.
- →Work with Investigators to ensure Data and Safety Monitoring Board (DSMB), Safety Monitoring Committee (SMC), or other safety reviews are completed in a timely manner.
- →Monitor key ethical and legal issues related to protection of research participants, adherence to policies and to Federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens and data.
- →Review documents for content, accuracy, and compliance with applicable regulations prior to submission to regulatory agencies.
- →Compile and maintain study essential regulatory document and files (digital and hardcopy) throughout the lifecycle of sponsorship.
- →Consult with research nurses, principal investigators, contractors, research sponsors, and regulatory personnel regarding regulatory issues and requirements and protocol adherence and interpretation.
- →Perform other duties as assigned.
Requirements
- ✓This position has an education requirement.
- ✓You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades).
- ✓Unofficial transcripts will be accepted in the application package.
- ✓Official transcripts will be required from all selectees prior to receiving an official offer.
- ✓Click here for information on Foreign Education.
Personality Fit
This role is commonly a great fit for these MBTI types:
Job ID: 4e78f42f-3240-4447-b524-d603bdcd90b1
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