Regulatory Operations Specialist (Remote)

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. The START Center for Cancer Research is seeking a Regulatory Operations Specialist I (Remote) who will prepare and submit documents for new and existing studies to the Institutional Review Board (IRB), US Food and Drug Administration (FDA), and Institutional Biosafety Committee (IBC) for review, maintain the Investigator Site File (ISF) for assigned investigational drug studies and corresponding documents at START USA sites. This is a remote role. The annual base salary for this role is $55,00 - $65,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. Essential Responsibilities - Prepare and submit new studies, including drafting the informed consent (IC), to the IRB as assigned under supervision. Serve as primary point of contact with the Sponsor/CRO in negotiating the IC for IRB submission. Serve as the main point of contact with the IRB for the studies. Enter work activity in Regulatory Operations tracking system(s) and generate status reports as required. Respond to inquiries and follow up on pending items. - Prepare and submit study documents to the IRB for assigned studies under supervision. This includes, but is not limited to, revised protocols, revised investigator’s brochures, protocol clarification letters/memos, revised ICs, new ICs, continuing review reports, closure reports, serious adverse events, IND safety reports, unanticipated problems, protocol deviations, waivers, etc. Serve as the main point of contact with the IRB for the studies. Enter work activity in Regulatory Operations tracking system(s) and generate status reports as required. Respond to inquiries and follow up on pending items. - Prepare and submit study documents to the Institutional Biosafety Committee (IBC) as assigned under supervision. Serve as the main point of contact with the IBC for the studies. Enter work activity in Regulatory Operations tracking system(s), note pending information and generate status reports as required. Respond to inquiries and follow up, as required, on pending items. - Prepare and submit Expanded Access Studies to the US Food and Drug Administration (FDA) as assigned under supervision. Serve as the main point of contact with the FDA and IRB for the studies. Enter work activity in Regulatory Operations tracking system(s) and generate status reports as required. Respond to inquiries and follow up, as required, on pending items. - Maintain ISF (paper and/or electronic) for assigned studies. This includes, but not limited to, IRB submissions, IRB approvals, and correspondence. - Prepare for and manage Close-Out Visits for assigned studies. - Attend assigned weekly Phase I meetings, and Site Initiation Visit meetings. Follow up with the appropriate department(s) and/or the Sponsor/CRO to address regulatory issues raised during the meetings and note updates in Regulatory Operations tracking system(s) with support. - Provide assistance during onboarding of new Regulatory Operations team members as needed. - Support Regulatory Operations Assistants as needed. - Complete assigned tasks and assist team to achieve departmental metrics and organizational key performance indicators. Required Education and Experience: - Bachelor’s degree or equivalent experience in lieu of degree. - 0-1 year experience in a regulatory research setting. - Proficient working knowledge of Microsoft Outlook 365. - Prior experience with regulatory document management system (i.e. Veeva, Advarra E-Reg). - Strong organizational skills and a sense of timeliness in completing projects. - Detail-oriented with good spelling, composition and proofreading skills. - Knowledge of medical terminology. - Ability to complete tasks with som…