Regulatory Assistant

• Prepare and maintain complete and accurate regulatory documents in support of clinical research studies.
• Manage all the communication with the IRB and Sponsor.
• Prepare each study-specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB.
• Supports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start up.
• Ensures regulatory submissions are done in a timely manner as to not delay study start up.
• Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, deviations, adverse event reports, and any other IRB-required submissions.
• Work with staff members to complete Financial Disclosure Forms for each study.
• Assist new hires in completing and submitting all required research documentation and training by their deadlines.
• Assist coordinators and site leadership in tracking the training status for existing staff, assisting with updates as needed.
• Ensure that all staff on the delegation of authority logs have the appropriate training on file.
• Maintain study binder, paper or electronic as appropriate, with all IRB related documents and correspondence for each study to always ensure audit readiness.
• Notify staff and Site Director of upcoming training expiration dates.
• Assist site leadership and coordinators in the preparation for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks of the regulatory binder.
• Assist with the preparation and submission of closeout documents to the sponsors and IRBs including ensuring completeness, audit-readiness, and closure of the regulatory binder and appropriate archival of trial data.
• Submit or support Protocol deviations submissions to the IRB as needed and in a timely fashion.
• Supports maintenance of DOA logs and any other required logs as needed.
• Submit or support SAE and AE submissions to the IRB as needed and in a timely fashion.
• Supports audit and inspection readiness by ensuring accurate and timely file completion.
• Provide copies of IRB documents to sponsors, as needed.
• Adhere to safety and compliance regulations.

• Bachelor's (Required)

• English (Required)

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