Clinical Regulatory Affairs Specialist I
New
S
Sarah Cannon Research InstituteOncology Research
US-based, full time, fully remoteFull-TimeEntry
Salary not disclosed
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Job Details
- Experience
- 1+ year
- Required Skills
- GCPHIPAA
Requirements
- High school graduation diploma required; Associate's Degree or higher preferred.
- Qualified experience may be substituted for education.
- 1+ year work experience in a clinical research, pharmaceutical, or site management organization, highly desired with a focus in regulatory affairs.
- Knowledge of medical terminology.
- Knowledge of FDA and other regulatory processes, highly preferred.
- Ability to manage a full study workload with minimal supervision.
- Proficiency in maintaining electronic document management systems.
- Familiarity with GCP and IRB regulatory documentation requirements.
- Understanding of protocol, informed consent forms, and HIPAA requirements.
Responsibilities
- Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks.
- Maintain a document management system for regulatory electronic files.
- Maintain FDA and GCP required regulatory documentation, ensuring compliance with local SOPs.
- Modify or develop informed consent forms and manage protocol, investigator drug brochure, and consent form amendments in compliance with IRB policy and HIPAA.
- Organize and process documentation for IRB submission for multiple trials.
- Process protocol deviations that meet IRB reportable criteria.
- Submit urgent safety notifications to the IRB.
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