Senior Clinical Research Associate

Essential Duties & Responsibilities

• Initiates, monitors, and closes-out investigative sites in accordance with FDA/ICH regulations.
• Tracks and maintains study specific non-Case Report Form database.
• Administers Clinical research projects; collects investigator documentation, site management, clinical contact, and prepare reports as required.
• Ensures appropriate source document review and source document verification as required.
• Reviews Case Report Forms to identify erroneous, missing, or incomplete data.
• Generates queries to resolve problematic data to appropriate personnel, and review responses to assure the database is updated accordingly.
• Verifies study drug accountability; generates and tracks drug shipments and storage.
• Trips as necessary, based on project needs and according to Clinical Monitoring Plan requirements.
• Develops and maintains strong relationships with Investigator(s) and site staff.
• Independently manages sites resulting in acceptable Quality Assurance reports.
• Escalates study/site issues/deviations appropriately.
• Serves as lead monitor for a protocol or project by creating study files, arranges monitoring schedules, leads the project team, organize and run meetings and performs other project management duties as assigned by management.
• Writes Clinical Trial Reports, analyzing and presenting trial results in a clear and accurate format.
• Reports, writes narratives, and follows-up on reported serious adverse events.
• Interacts and attends client meetings, as appropriate.
• Mentors junior staff/CRAs.
• Quality oversight checks of monitoring.
• Performs other duties as assigned.

Qualifications

• Bachelor’s degree, or RN, in a related field or equivalent combination of education, training and experience.
• Minimum 5 years’ experience as a CRA; experience overseeing clinical trials in the pharmaceutical, hospital or CRO industry.
• Experience with numerous EDC systems.
• Advanced knowledge of GCPs, ICH guidelines, FDA and other applicable regulations.
• Specialized knowledge of CNS therapeutic areas.
• Proficiency in Microsoft Office, Zoom and Adobe.
• Excellent writing and verbal skills, English language proficiency.
• Meticulous attention to detail.
• Time management and ability to prioritize tasks.
• Ability to travel up to 70%.