Regulatory Affairs Specialist

Regulatory Affairs Specialist, Oncology Clinical Research Ensure all your application information is up to date and in order before applying for this opportunity.*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. xhmxlyz Sharp attention to detail, with strong spelling, composition, and proofreading skills.