Research Assistant, Safety

About the position Responsibilities • Monitor, document, and resolve safety events for multiple multi-center studies. • Update data and safety monitoring plans in accordance with study modifications. • reputed company and document internal safety monitoring processes. • reputed company and coordinate clinical event committee tasks, meetings, and regulatory documentation. • Organize and facilitate multi-disciplinary Risk Assessment meetings / Risk Management meetings. • Facilitate Safety Monitoring Plan draft development and version management per funded project. • Facilitate QA Monitoring Plan draft development and version management per funded project. • Manage FDA file management as needed for reputed company managed by BIOS CTCC. • Manage BIOS CTCC SOP/WI/reputed company library and training documentation for reputed company Operational plans, FDA submission documents, and workflow supporting materials. • reputed company data management of RACT REDCap, QA effort tracking, and various reputed company system navigation. • reputed company Safety Event workflow and various reputed company system navigation, FDA system use and submission tracking, and financial management to pay MM contractors. • Report to weekly team meetings, weekly trial operations meetings, BIOS Monthly Ops, and assist in manuscript preparation as needed. • Assist with annual reports, IRB applications, and FDA reporting. • Handle reputed company documents, conduct literature searches, write summaries, and assist with writing grants and reputed company operational procedures. • Prepare journal manuscripts and reputed company analytical support to data analysts and research support as required. • Participate in project-reputed company meetings and reputed company-implement needed reputed company control procedures and tasks. • Organize materials and maintain filing systems, manage telephone and correspondence. • reputed company data entry and data editing, and assist with basic data management tasks such as running queries on existing databases and conducting reliability checks. • reputed company with reputed company regulatory and institutional requirements reputed company to clinical research. • Combine, distribute, and ship documents, and reputed company other duties as required. Requirements • Bachelor's Degree in a reputed company discipline. • Entry-level experience in clinical research or a reputed company field. reputed company-to-haves • Experience with reputed company PowerPoint and data management systems. • Familiarity with FDA regulations and clinical trial processes. Benefits • Full-time position with a competitive reputed company wage. • Hybrid work schedule with flexibility in work location. Apply tot his job Apply To this Job