Clinical Trial Specialist

Position: Clinical Trial Consultant IILocation: 140 6th St, Cambridge, MA 02142Duration: 12-Month Contract (Potential Extension or Conversion to Full-Time)Compensation: $50.00 – $60.22/hr on W2Benefits: Weekly Pay, Medical, Dental, and Vision CoverageJob Summary:The Clinical Trial Consultant II will be responsible for case processing and quality control (QC) of clinical trial ICSRs and post-market case processing from sanctioned countries.Key Responsibilities:Perform triage, intake, case entry, and QC of ICSRs originating from Client-sponsored studies and other assigned casesPrepare narratives, perform MedDRA coding, draft follow-up queries, and issue event notifications to internal stakeholdersConduct retrospective quality checks on processed casesIndependently manage assigned cases, including weekend and holiday coverage, to ensure timely case completion and regulatory reportingCollaborate with Data Management to review and resolve reconciliation issues between clinical and safety databasesSupport investigations related to delayed regulatory reporting of clinical trial casesRequired Skills & Qualifications:Strong knowledge of global and local safety regulationsExcellent written and verbal communication skillsHands-on experience with safety databases such as ArisG, Argus, and VeevaSolid understanding of FDA, ICH, and EU pharmacovigilance regulations and reporting requirementsProficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)Strong understanding of medical terminology, clinical practices, and medical conceptsEducation & Experience:Bachelor's degree in Science, Healthcare, or a related fieldMinimum 4+ years of Pharmacovigilance experience