The Safety Associate supports clinical trial safety management by ensuring compliance with regulations, managing adverse event reports, and preparing safety data and reports for stakeholders.
The Safety Associate provides technical and process-related support to clinical trial safety management and medical monitoring activities, ensuring compliance with applicable regulatory requirements and Standard Operating Procedures (SOPs). This role requires sound judgment and professional knowledge to ensure complete, accurate and timely safety reporting.
- Serve as resource for protocol-specific and/or general clinical trial safety reporting requirements
- Assist with writing or reviewing safety monitoring documents, including safety management plans.
- Manage the receipt and processing of adverse event reports (i.e., SAE, UADE, AESI, pregnancy case and/or other protocol-specified case reports) to include entry of safety data into adverse event database(s) as required and tracking systems as well as review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- Develop and coordinate resolution of safety data queries; obtain supplemental documents as needed
- Write patient narratives and draft MedWatch and/or CIOMS Forms as needed
- Coordinate Medical Monitor review of safety data; extract data from the study database or external data portal and prepare data listings as needed
- Provide safety reports to the sponsor and project team members (i.e., Project Manager, Biostatistician, Medical Writer) as required and/or outlined in approved Safety Management Plans
- Assist with the unblinding of treatment assignment as needed
- Complete medical coding, once trained, as needed
- Assist with safety data reconciliation as assigned
- Maintain safety records and associated documentation in approved systems as required
- Actively participate in project meetings as required and represent safety services at bid defenses when requested
- Attend Investigator meetings and/or present safety reporting requirements as needed
- Facilitate CEC/DMC/DSMB meetings and performs associated tasks as assigned
- Assist with project safety service proposal development as assigned
- Maintain expertise through continuing education and review of current industry literature
- Support other company initiatives and cross-functional team projects as assigned
- Perform other duties as assigned
Requirements
- A Bachelor’s degree, preferably in science or a health-related field, with at least three years of drug safety experience is preferred; however, a combination of education, training and experience will be considered
- MedDRA coding certification is preferred
- Strong knowledge of US federal regulations, ICH guidelines, and HIPAA as applicable to safety reporting in clinical trials
- Strong computer skills with knowledge of safety database management and clinical data management systems; proficiency in at least two EDC platforms is preferred
- Excellent interpersonal skills and ability to work well with sponsor representatives, Medical Monitors, clinical investigators and site personnel and multidisciplinary project team members
- Excellent communication skills (verbal/written/presentation)
- Proven ability to plan, prioritize, and manage a workload independently with a high degree of initiative and attention to detail
- Demonstrated problem solving skills including successful resolution and proactivity
Communications
- Communicates effectively and objectively
- Professional and effective team and sponsor communication
- Able to present to large groups, including peers, team members and other project-related personnel
- Organizes, participates and facilitates internal and external meetings
- Maintains electronic files that can be accessed by appropriate personnel
- Uses applicable systems to communicate with personnel
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