Piper Companies is looking for a S & P Associate to join a clinical research organization located in Bethesda, MD. Responsibilities of the S & P Associate include: Manage and process Serious Adverse Events (SAEs) in accordance with project-specific requirements. Maintain and organize safety documentation, electronic files, and tracking systems while supporting document control activities. Track and process pharmaceutical and Data Management Center (DMC) queries and generate requested safety data reports. Process safety narratives, assist with MedDRA coding activities, perform quality control reviews on AE submissions, and distribute safety information as required. Qualifications for the S & P Associate include: Bachelor's degree with at least 1+ years of clinical research or safety experience, or a scientific/health-related Master's degree with relevant internship experience. 1+ years of experience in a clinical research environment or bioethics setting. Knowledge of medical terminology and familiarity with medical research data, experimental protocol review, safety data summarization, and the drug/vaccine development process or clinical trials. Compensation for S & P Associate includes: Rate Range: $25-$29/ hr, depending on experience Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law Keywords:Drug Safety, Pharmacovigilance, Safety Operations, Serious Adverse Events (SAEs), Adverse Events (AEs), SAE Processing, Case Processing, Safety Narratives, IND Cases, Non-IND Cases, MedDRA Coding, AE Reconciliation, Safety Database Management, Safety Reporting, Clinical Safety, Regulatory Compliance, GCP, ICH Guidelines, FDA Regulations, Clinical Research, Clinical Trials, Drug Development, Vaccine Development, Safety Surveillance, Signal Detection, Data Management, Data Analysis, Data Quality Control, QC Review, DMC Queries, Medical Terminology, Medical Research Data, Safety Documentation, Document Control, Regulatory Submissions, Site Communications, Safety Communications, Safety Distributions, Medical Monitoring Support, Protocol Review, Safety Data Review, Electronic File Management, SharePoint, Microsoft Excel, Microsoft Word, Microsoft Outlook, SPSS, SAS, R, Clinical Operations, Research Compliance, Biomedical Research, Life Sciences, Healthcare Research, Case Tracking, Report Generation, Pharmacovigilance Operations
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