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. • Develop and document internal safety monitoring processes. • Develop 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 projects managed by BIOS CTCC. • Manage BIOS CTCC SOP/WI/Form library and training documentation for all Operational plans, FDA submission documents, and workflow supporting materials. • Perform data management of RACT REDCap, QA effort tracking, and various EDC system navigation. • Track Safety Event workflow and various EDC 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 source documents, conduct literature searches, write summaries, and assist with writing grants and standard operational procedures. • Prepare journal manuscripts and provide analytical support to data analysts and research support as required. • Participate in project-related meetings and develop-implement needed quality control procedures and tasks. • Organize materials and maintain filing systems, manage telephone and correspondence. • Perform data entry and data editing, and assist with basic data management tasks such as running queries on existing databases and conducting reliability checks. • Comply with all regulatory and institutional requirements related to clinical research. • Combine, distribute, and ship documents, and perform other duties as required. Requirements • Bachelor's Degree in a related discipline. • Entry-level experience in clinical research or a related field. Nice-to-haves • Experience with Microsoft PowerPoint and data management systems. • Familiarity with FDA regulations and clinical trial processes. Benefits • Full-time position with a competitive hourly wage. • Hybrid work schedule with flexibility in work location. Apply tot his job