Job Description

Responsibilities :

• 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.

Requirements:

• Associate or bachelor’s degree required, preferably in life sciences or health-related field.
• 3–5 years of clinical research regulatory affairs experience.

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