Are you interested in supporting cutting-edge research in support of the US Government and private sponsors? The Life Sciences Group at Leidos currently has an opening for a Clinical Research Associate, Safety Specialist, based in Frederick, Maryland. This person will create and manage processes to ensure adverse events are reviewed and handled in accordance with regulatory requirements, as well as with Leidos’ procedures and ethical standards, to ensure patient safety in clinical trials.
• Develop Safety training for study sites. Educate and provide training to sites to ensure proper reporting of AE’s and adherence to protocol requirements
• Actively collaborate in the development of Safety trainings
• Act as resource to subcontractors. When appropriate, perform Quality Control on subcontractors’ work
• Assist in development of safety processes, committee charters and other safety related documents
• Assist in review of and/or preparation of safety related sections and associated documentation for clinical and regulatory documents, including clinical study protocols, clinical study reports, annual reports, etc.
• Collaborate with other team members to develop report specifications and content.
• Review and assess site reported adverse events (AEs) and other clinical trial data for potential safety issues. Perform thorough review of medical records to ensure proper reporting of events per study protocol and definitions, and identification of unreported events. Differentiate events by assisting Safety Officer in performing assessment of seriousness, relatedness to device and procedure, and expectedness
• Generate clinically relevant AE queries in the clinical database in order to obtain missing or discrepant information; follow up with the enrolling sites until complete resolution, if necessary
• Identify potential safety trends and escalate to management
• Assist with AE/SAE reconciliation prior to clinical trial database closure/lock
• Interface with external partners [i.e. Sites, CRO, Data Safety Monitoring Board (DSMB)] to provide oversight on all safety processes from the enrolling site to the CEC and DSMB, to ensure process flow is managed efficiently and effectively.
• Prepare medical case narratives for serious adverse events, utilizing clinical background and experience, by integrating case-related information from source documents (to be used for cross functional activities, including, but not limited to regulatory reports and submissions).
• Other incidental duties, including occasional participation in internal or external audits, and travel, when required
• 5 years of previous hands-on clinical research related experience
• BA/BS degree in life sciences, or similar field preferred.
• Strong written and verbal communication skills
• Excellent organizational and time management skills
• Display appropriate professional behavior in business-related interactions
• Ability to prioritize and complete multiple tasks concurrently
• Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification)
• Proficient in Spanish or Portuguese