Regulatory Affairs Specialist - Oncology Clinical Research

About the Role

Join a prominent oncology clinical research organization dedicated to connecting patients with innovative cancer therapies and facilitating advancements through clinical trials.

Key Responsibilities

• Prepare and submit all necessary documentation to the Institutional Review Board (IRB) for assigned investigational drug studies, which includes protocol amendments, informed consent forms, continuing review reports, and safety updates.
• Act as the primary liaison with the IRB by tracking submission deadlines, monitoring outstanding requirements, and ensuring timely follow-up until completion.
• Manage and maintain the Investigator Site File for each assigned study, ensuring IRB approvals, correspondences, and study-related documents are organized and up-to-date.
• Organize and oversee study close-out visits and support Site Initiation Visits by verifying receipt and distribution of all essential documents to the study team prior to meetings.
• Coordinate the collection of signatures on critical regulatory documents such as FDA Form 1572, protocols, and investigator brochures; dispatch initial regulatory packets to sponsors or contract research organizations (CROs).
• Participate in weekly meetings including study start-up, Phase I discussions, and site visit meetings, proactively addressing and resolving regulatory issues by liaising with relevant departments or sponsors.

Requirements

• Bachelor's degree or relevant equivalent experience in lieu of formal education.
• Minimum of two years' experience working within a regulatory research environment.
• Proficiency in Microsoft Word and a strong command of document creation and management.
• Exceptional organizational capabilities to effectively handle multiple concurrent clinical studies and deadlines.
• Meticulous attention to detail, excellent spelling, strong written communication, and proofreading skills.