Job Description
Location: Remote Position Pay Range: $25.19 - $44.31 Job Description Summary: Research Regulatory Coordinator is responsible for collaborating with the PI’s and internal and external members of the clinical research team within scope of clinical trial regulatory submission and compliance. Assist in preparing regulatory submissions and maintaining the regulatory files. Coordinate the preparation of regulatory documents for submission to the Institutional Review Board (IRB) or other IRB’s as determined, other internal committees and the FDA as necessary including but not limited to: Initial documents submission; Continuing Reports; Amendments and addendums to research protocols and consent documents and Adverse Event reporting. Collaborate with study team members to perform these duties. Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures. Primary Key Performance Areas: KPA 1 – Creates and maintains central regulatory files in accordance with site SOP. Adhere to and maintain working knowledge of practice policies, the Federal regulations, ICH, and GCP guidelines. In compliance with the Code of Federal Regulations under the Health Insurance Portability and Accountability Act (HIPAA), assure that patient records will be kept confidential and secure. Maintain the investigative site study files and regulatory binders. Responsible for the preparation of archiving closed studies for long-term storage Collect and maintain study specific documentation (for main and satellite locations as needed) in the appropriate Regulatory Binder as well as the electronic document system including: Create and maintain the Research Delegation of Au
