Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision, the regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation. Reporting to Director of Clinical Research will prepare and process, with minimal supervision, all initial oversight submissions for regulatory documentation through the IRB, FDA and all applicable institutional regulatory review committees. In collaboration with clinical research teams and investigators he/she will prepare, and process all required regulatory documentation for NIH, pharmaceutical companies, contract research organizations (CROs), and the FDA, as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Start-Up Specialist is expected to resolve, with minimal supervision, regulatory queries, and participate in the initiation of the new study, as well as, communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation. He/she will participate in regulatory staff meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Start-Up Specialist- is expected to oversee, with minimal supervision, the development of investigator-initiated research protocols, grant applications, the development and submission of FDA IND applications, and the development of study specific forms and source document tools, as well as, to provide direct regulatory/compliance guidance and oversight of investigator-initiated trials and investigator-initiated multi-site trials. Bachelors degree and 3-5 years of experience or an equivalent combination of education and experience required.
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