Regulatory Affairs specialist
Company: Katalyst Healthcares & Life Sciences
Posted on: March 20, 2023
- Oversee the smooth-running of regulatory processes at the
- Assist in formulating and carrying out Standard Operating
- Review SOPs with Clinical Operations lead to ensure they abide
by local, state, GCP, ICH, and FDA guidelines.
- Ensure all required regulatory documents and IRB submissions
are completed in a timely manner.
- Ensure clinical staff completes the study initiation checklist
prior to patient screening.
- Regularly perform quality checks for all regulatory
- Participate in kick-off meetings to ensure all regulatory
documents are in place.
- 5years of regulatory experience in a hospital, clinical or
- Experience with Central IRBs and Local IRBs.
- Knowledge and understanding of regulatory terminology,
regulations (including HIPAA policies and procedures), clinical
trials, and GCP concepts.
- clinical research experience is highly preferred!
Keywords: Katalyst Healthcares & Life Sciences, Rochester , Regulatory Affairs specialist, Other , Rochester, New York
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