Regulatory Affairs Specialist

Regulatory Affairs Specialist, Oncology Clinical Research

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5-6 Month Contract

Join a leading oncology clinical research organization known for connecting patients with cutting edge cancer treatments and advancing new therapies through clinical trials.

• In this role, you will prepare and submit study documents to the IRB for assigned investigational drug studies, including protocol amendments, informed consent forms, continuing review reports, and safety reports.
• You will serve as the main point of contact with the IRB, tracking submission dates, monitoring pending items, and following up until resolution.
• You will maintain the Investigator Site File for each assigned study, keeping IRB approvals, correspondence, and study documents organized and current.
• You will prepare and manage study close out visits, and support Site Initiation Visits by confirming all required documents are received and distributed to the study team beforehand.
• You will coordinate signatures on essential regulatory documents such as Form FDA 1572s, protocols, and investigator brochures, and send the initial regulatory packet to the sponsor or CRO.
• You will attend weekly study start up meetings, Phase I meetings, and site visit meetings, following up with the appropriate department or sponsor to resolve regulatory issues raised.

What you need

• A bachelor's degree, or equivalent experience in place of a degree.
• At least two years of experience in a regulatory research setting.
• Strong working knowledge of Microsoft Word.
• Excellent organizational skills with the ability to manage multiple studies and deadlines at once. xhyhwjd
• Sharp attention to detail, with strong spelling, composition, and proofreading skills.