Regulatory Affairs Specialist Senior (Department of Ophthalmology)

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Posted Job Title

Regulatory Affairs Specialist Senior (Department of Ophthalmology)

Job Profile Title

Regulatory Affairs Specialist Senior

Job Description Summary

Ophthalmology seeks part-time Regulatory Affairs Specialist-CC to facilitate, with minimal supervision, the development of investigator-initiated research protocols (including those involving fellows, residents, and medical students), 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. 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 the Director of Clinical Research at the Scheie Eye Institute, 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 the National Institutes of Health (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 Specialist will also help Clinical Research Coordinators (CRC) within the Department of Ophthalmology answer any regulatory questions. He/she will also perform audits of protocols every 6 months to ensure compliance.

Position is contingent on funding.

Job Description

Job Responsibilities

• Development of investigator-initiated research protocol