Regulatory Coordinator I

The Regulatory Coordinator I reviews and submits clinical trial protocols to the Institutional Review Board (IRB), ensuring compliance with local, state, and federal regulations such as ICH/GCP guidelines. This role provides administrative support to the regulatory team by tracking submissions, maintaining essential documentation, and managing tracking tools for various regulatory forms. Candidates will independently process IND Safety reports and collaborate with staff to maintain efficient procedures for the management of regulatory aspects in clinical trials.