Regulatory Coordinator position within a large academic institution in Southern California. The Regulatory Coordinator will support a research portfolio of 40 sponsor-initiated clinical trials in neuro oncology.
- Submit protocols and supporting documents to regulatory bodies, such as central and local IRBs.
- Maintain regulatory binders. Collect all relevant documents and signatures.
- Create and amend Informed Consent Forms (ICFs).
- Draft and submit financial disclosure and 1572s. May contribute to developing budgets.
- Submit continuations and amendments.
- Attend site initiation visits.
- Generate reports and maintain research files and documentation, as per study protocol.
- Work with internal staff to insure all regulatory documents and requirements are met and up-to-date.
- Communicate with sponsor companies.
- Maintain research practices using Good Clinical Practice (GCP) guidelines. Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
- 3+ years of relevant clinical research experience
- Experience submitting to IRB
- Bachelor's degree preferred
- ACRP/CCRC certifications preferred
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