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Job: Clinical Research Associate, Scion NeuroStim, LLC, Raleigh, NC
Clinical Research Associate
Raleigh, NC 27613 United States
10108 Darling St
Scion NeuroStim, LLC is seeking a Clinical Research Associate (CRA) to perform site activities for clinical trials investigating a novel medical device while operating as the main point of contact for each of the clinical sites during a study. The CRA will execute monitoring plans, ensure site GCP compliance, resolve issues and facilitate open-issue resolution, work on recruitment strategies, monitor safety at clinical sites and verify that the rights and well-being of human subjects are protected. The CRA will conduct site qualification visits as assigned, site initiation visits and site training, routine monitoring visits, and site close-out visits while verifying all trial data are accurate and complete. The CRA will perform investigator site management activities in adherence with the currently approved protocol/amendment(s), with Good Clinical Practice, all applicable regulatory requirements and standard operating procedures (SOPs).
• Adhere to corporate internal polices and requirements
• Knowledge of applicable SOPs, guidelines and study procedures
• Assist with preparation of trial-related documents (Protocols, Case Report Forms, Investigators Brochures/Manuals, Informed Consent Forms, Institutional Review Board submissions)
• Assist study feasibility and site selection activities, document all investigator information and study contacts, and assist with execution of investigator agreements/contracts and budget negotiations
• Collect and review site regulatory documents
• Assist with investigator/site meeting activities including organization and preparation
• Provide status of site activity to the Management Representative
• Perform site management activities including, but not limited to, site qualification visits, site initiation visits, site training, site routine monitoring visits, and site close out visits
• Maintain frequent telephone and email communication with sites, providing guidance on operational site issues to study coordinators and investigators as necessary and in agreement with investigational plans
• Write study visit reports and follow-up letters within the timeline established by the applicable SOPs and guidelines
• Follow-up of safety issues and safety reports in timely manner, if required
• Conduct review and validation of Case Report Forms
• Assist with data query resolution
• Review all patient tracking records
• Input and maintain study information in tracking systems
• Assist with administrative activities, as needed, as a member of the project team
• Attend staff/project team meetings as required
• Close down study centers upon completion of a clinical trial.
Must have a degree in an allied health field such as Nursing or Health Science and a minimum of two years of clinical research experience. Specific experience with clinical research in Parkinson’s disease or neurodegenerative disorders and experience working with medical devices is preferred but not required. Previous experience overseeing a multicenter randomized clinical trial is also preferred. Must have excellent verbal and written communication skills and computer literacy using MS Word, Excel and PowerPoint. Must have excellent organizational, record retention, and time management skills as well as excellent customer service and interpersonal skills. Must have knowledge of ICH-GCP, FDA & local regulatory requirements. Must have disciplined and organized approaches to all aspects of assignments.
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