The Senior Clinical Research Associate is responsible for overseeing the execution of clinical trials at Investigative Sites. The Clinical Research Associate acts as a liaison between the study Sponsor, CRC and Investigative Sites. They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. The CRA facilitates successful execution of studies by Investigative Sites and helps to ensure the rights, safety and welfare of human research participants as well as data integrity in clinical trials.
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
- 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
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
- 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%
