Regulatory Operations Specialist

START Center for Cancer Research

77d•$25 - $28•Remote

About The Position

The Regulatory Operations Specialist prepares and submits regulatory documents for new and existing studies to the Institutional Review Board (IRB), the U.S. Food and Drug Administration (FDA), and the Institutional Biosafety Committee (IBC). The role maintains the Investigator Site File (ISF), in paper and/or electronic form, for assigned investigational drug studies and related documents at START USA sites. This is a remote position. Under supervision, the Specialist prepares new study submissions, including drafting informed consent documents, and coordinates with Sponsors/CROs and IRBs. The role also prepares and submits study documents and Expanded Access Studies to the relevant committees and agencies, tracks activity and status, responds to inquiries, and follows up on pending items. The position is paid hourly at $25–$28; base pay may vary based on market location and job-related knowledge, skills, and experience.

Requirements

High school diploma or GED.
Five years of experience in a regulatory research setting.
Proficient working knowledge of Microsoft Outlook 365.
Prior experience with a regulatory document management system, such as Veeva or Advarra E-Reg.
Strong organizational skills and a sense of timeliness in completing projects.
Strong knowledge of medical and clinical research terminology.

Nice To Haves

Bachelor’s degree.

Responsibilities

Prepare and submit new studies to the IRB, including drafting informed consent documents, under supervision.
Serve as the primary contact with Sponsors/CROs to negotiate informed consent documents for IRB submission.
Serve as the main point of contact with the IRB for assigned studies.
Prepare and submit study documents to the IRB, including revised protocols and investigator’s brochures, clarification letters or memos, informed consent documents, continuing review reports, closure reports, serious adverse events, IND safety reports, unanticipated problems, protocol deviations, and waivers.
Prepare and submit study documents to the IBC as assigned under supervision and serve as the main point of contact with the IBC for those studies.
Prepare and submit Expanded Access Studies to the FDA as assigned under supervision and serve as the main point of contact with the FDA and IRB for those studies.
Enter work activity in Regulatory Operations tracking systems, note pending information, and generate status reports as required.
Respond to inquiries and follow up on pending items.
Maintain paper and/or electronic ISFs for assigned studies, including IRB submissions, approvals, and correspondence.