I am a highly motivated, detail-oriented professional with over 10 years of experience in the healthcare industry. I have a strong background in the medical field.
management, regulatory affairs, clinical trial, records management, clinical
Eastern State Hospital
Provide clinical trial management for investigational sites and ensure adherence to all regulatory requirements and HIPAA regulations. Maintain and update the study specific files.
Lead the TMF team to ensure that all regulatory documents are compliant with cGMP and ICH guidelines and 21 CFR 820.
Review and approve all regulatory documents for submission to the IRB, including the approval of the study Master files, TMF and the appropriate documentation.
Assist in the development of the study Master file (TMF) for the TMF and in house management. Review and approve regulatory documents for completeness and accuracy.
Monitor the regulatory documents and ensure the TMF is up to date on all relevant documents in the TMF. Provide training to the site staff in compliance with GCP guidelines.
Review and approve regulatory documents for submission to regulatory authorities. Assist in the development of protocols and amendments. Ensure that all study related documents are complete and accurate.
Regulatory Affairs Assistant
Review and approve regulatory documents for submission to the FDA. Ensure that all regulatory submissions are submitted to the FDA.
Provide regulatory guidance to the investigational sites to ensure that the trial is in compliance with the FDA regulations. Manage the preparation of the submission documents for the FDA.
Review clinical data for accuracy and completeness, and ensure that all study documents are complete and accurate. Ensure that all regulatory documents are up to date.
Knowledge of FDA regulations, ICH guidelines, and other regulatory requirements. Ensure that all regulatory documents are current and current.