We are looking for someone who will perform the following job duties : Reviews clinical data/information and oversees data correction. Work with the Clinical Study Manager to satisfy applicable regulatory standards. Evaluates and analyzes clinical data. Designs experimental protocols and patient record forms.
Review and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs). • Conduct Case Management in the Clinical Safety Database. • Interacts with investigational sites and field monitors to obtain additional pertinent information as indicated. • Works with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.g., SAEs , adverse events (AEs), and device deficiencies). • Works with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed. • Ensures appropriate distribution and notification of SAEs and UADEs to appropriate personnel, partners, and clinical centers for protocol(s). • Liaison for safety-related questions ( e.g., to study team, field support, monitors, and study sites) • Write Clinical Safety plan for assigned protocol(s). • Assists with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required. • Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms. • Assists with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings. • Performs other duties as assigned.
