Senior Regulatory Specialist

Job Description

The Senior Regulatory Specialist is the subject matter expert and leader of a regulatory team to prepare and maintain complete and accurate regulatory documents in support of clinical research studies. Responsibilities Role & Responsibilities: Leads a team of multiple regulatory specialists supporting one or more Velocity Clinical Research sites Ensures regulatory submissions are done in a timely manner as to not delay study start up. Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB. Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, adverse event reports, and any other IRB-required submissions. Work with staff members to complete conflict of interest paperwork for each study. Assist new hires in completing and submitting all required research documentation and trainings. Track training status for existing staff, assisting with updates as needed. Maintain study binder with all IRB related documents and correspondence for each study. Maintain electronic regulatory files, including tracking document history. Maintain a database of staff listings and training dates. Pro-actively notify staff and Site Manager/Director of upcoming training expiration dates to maintain compliance Coordinate meetings with auditors to review paper and electronic regulatory files and inspectors. Provide copies of IRB documents to sponsors, as needed. Adhere to safety and compliance regulations. Stay abreast of evolving regulatory trends and work with the Site Manager/Site Director to ensure compliance with changes in the regulations Ensures binder accuracy, completeness and inspection readiness Prepare local IRB submissions Review ICFs for completeness - ensure the California Bill of Rights is included as applicable, subject stipends are accurate, and all protocol procedures are captured in the ICF Ensures that ICFs and other study documents are available in any language as required by the site and approved by the IRB Works with the Velocity IRB of record to submit generic site material Other duties as assigned Qualifications