● Prepares and submits regulatory documents to IRBs and sponsors independently.
● Maintains regulatory binders electronically and in the CTMS in compliance with regulations
governing clinical research GCP and site SOPs.
● Drafts and revises ICFs, site-specific regulatory forms, and other regulatory documents.
● Coordinates responses to IRB queries and sponsor requests for information.
● Serves as the primary regulatory point of contact for assigned studies.
● Participates in internal audits and regulatory reviews.
● Supports and mentors Regulatory Assistants in task completion and training.
● Monitors document version control and conduct routine regulatory QC checks.
● Occasional travel to Company sites, Investigator meetings, and/or Company meetings as required.
● Performs other miscellaneous job-related duties as assigned by their manager.
● This job description is not an exhaustive list of all the functions that you may be required to
perform. The Company reserves the right to revise this job description at any time.