SUMMARY DESCRIPTION The Clinical Research Associate (CRA) will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Standard Operating Procedures. This position requires proven monitoring skills. The CRA conducts site visits to assess site adherence to protocol and regulatory requirements as well as manages required documentation. The CRA will also be responsible for ensuring the data remains audit ready and able to pass an audit.
*This individual will need to periodically travel onsite in NYC, but will work remote most of the time.
Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV).
Contribute to the development and review of protocols, study tools, and materials as well as documentation for clinical trials.
Develop and maintain effective working relationships with clinical sites and ensure communication of project goals and critical requirements.
Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits.
Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.
Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.
Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as required.
Develop and implement study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution.
Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance.
Ensure that studies adhere to FDA regulations and Good Clinical Practices.
Perform both onsite & remote monitoring and study closure activities across multiple protocols.
Bachelor’s or Master’s degree in a scientific discipline.
Knowledge of ICH GCP and FDA regulatory requirements is required.
Research or health care related academic or work experience preferable.
Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
Good written and verbal communication skills.
Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.
The salary for this position is budgeted $70,000-$80,000
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