Regulatory Affairs specialist

Company: Katalyst Healthcares & Life Sciences
Location: Rochester
Posted on: March 20, 2023

Job Description:

Responsibilities:

Oversee the smooth-running of regulatory processes at the site(s).
Assist in formulating and carrying out Standard Operating Procedures (SOPs).
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 documents.
Participate in kick-off meetings to ensure all regulatory documents are in place.

Requirements:
- 5years of regulatory experience in a hospital, clinical or healthcare setting.
- 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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