The Department of Neurology is seeking a Research Assistant, Safety that will support the BIOS Clinical Trial Coordinating Center (CTCC), which manages multi-center, 20+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials.
Specific Duties & Responsibilities
Safety and Risk Assessment, Surveillance, and Management
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
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, workflow supporting materials (email templates, CAPA plans, etc.),
Data management of RACT REDCap, QA effort tracking and various EDC system navigation, Safety Event workflow tracking and various EDC system navigation, FDA system use and submission tracking, financial management to pay MM contractors
Report to weekly team meeting (per team), weekly trial operations meetings (per trial supported), BIOS Monthly Ops (monthly), manuscript preparation (ad hoc)
Research Support
Assist with annual reports, IRB applications, and FDA reporting.
Handle source documents, literature searches, write summaries, assist with writing grants and standard operational procedures, and prepare journal manuscripts.
Provide analytical support to data analysts and research support as required to include PowerPoint presentations and general correspondence.
Participate in project related meetings and develop-implement needed quality control procedures and tasks. Organize materials and maintain filing systems.
Provide telephone and correspondence management.
Perform data entry and data editing.
Assist with basic data management tasks such as running queries on existing databases, organizing, and editing data, conducting reliability checks.
Comply with all regulatory and institutional requirements related to clinical research.
Combine, distribute, and ship documents.
Perform other duties as required.
Minimum Qualifications
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Classified Title: Research Assistant Job Posting Title (Working Title): Research Assistant, Safety Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $17.20 - $30.30 HRLY (Commensurate with experience) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Non-Exempt Location: Hybrid/School of Medicine Campus Department name: SOM Neuro BIOS Personnel area: School of Medicine
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