Medical Operations Specialist
Current- Ensures records of medical monitor contacts are archived in the Trial Master File.- Supports study-related committees and meetings between sponsor and SYNH medical expertsby attending meetings, preparing meeting minutes, and maintaining archiving all related documents.- Uploads and manages documents collected for pre-enrollment review and endpoint adjudication into systems, including the Trial Master File- Physician and Scientist staff with documentation and archival of their deliverables and TMF relevant correspondence- Ensures receipt and direction of laboratory and vendor alerts to the appropriate physician, and follows the alert to ensure site outreach and archival of site correspondence.- [SAS] May Assist Medical Affairs Scientists with review of medical data listings, Case Report Form (CRF) line and lab listings, and medical coding in support of Scientific Review duties.- Ensures compliance with the Code of Federal Regulations (CFR), HIPAA, state regulations, International Committee on Harmonization (ICH), and GCP guidelines, and sponsor Standard -Operating Procedures (SOPs), and Work Instructions (WIs), where appropriate.- Studies worked on include: Oncology, Endocrinology/Metabolism, Dermatology, Neurology, Respiratory, Immunology/Inflammation, Hepatology