Note: The job is a remote job and is open to candidates in USA. Cognitive Research Corporation is seeking a Senior Clinical Research Associate to oversee the execution of clinical trials at Investigative Sites. The role involves acting as a liaison between the study Sponsor, CRC, and Investigative Sites, ensuring the rights and safety of research participants while maintaining data integrity during clinical trials.
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
- Travels as necessary, based on project needs and according to Clinical Monitoring Plan requirements
- Performs data collection, retrieval, entry and clean up as necessary
- 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
Skills
- 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
- Ability to work and travel independently with minimal supervision
- 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%
Company Overview
Company H1B Sponsorship