(Senior) Clinical Research Associate - Sponsor Dedicated
Join our sponsor dedicated team and work on unique and dynamic trials as a CRA. This home-based role will allow you to monitor clinical trials using IQVIA’s cutting edge technology and systems in a fast paced, ever changing life science industry.
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
This is a role that does require up to 70% travel within a region.
• Perform pre-trial contact, initiation, periodic on-site and closeout visits, in accordance with trial protocol, monitoring manual, Investigator Site File (ISF) and other related documents. Submit quality trip reports and related documents on time.
• Assist in the identification and selection of qualified investigators by critical evaluation and documentation of the qualifications of investigators and research staff and the adequacy of site facilities.
• Assure that investigator and other site staff understand the protocol, amendments, and regulatory responsibility.
• Identify, report and monitor adverse events while performing monitoring activities. Ensure investigator compliance with reporting adverse events to the sponsor and the Institutional Review Board (IRB).
• Monitor storage, administration, dispensing and return of investigational product during the trial initiation and throughout the trial.
• Performs review and verification of study data/source data (including, but not limited to all medical charts (paper or electronic), shadow charts, vendor reports) in accordance with the protocol, monitoring manual and other related documents, FDA regulations, ICH/GCP guidelines, Sponsor SOPs and Sponsor Working Instructions. Routinely reviews the status of case report forms for assigned trials.
• Perform routine review and verification of Investigator Site File, assuring consistency with the Trial Master File (TMF) and timely submission of documents to TMF, per Sponsor processes.
• Monitor the progress site monitoring activities for assigned sites on an ongoing basis in accordance with timelines and monitoring plan. Identify enrollment and operational problems, issues, and obstacles for assigned sites. Communicate any changes, patterns and trends to the CRA Manager or designee and the local Clinical Trial Manager (CTM) in a timely manner. Ensure compliance issues are escalated and corrective actions taken. Participate and facilitate efforts to implement appropriate and timely interventions in order to resolve issues and meet timelines.
• Participate in trial-related meetings including but not limited to Investigator Meetings, Site Escalation, and Protocol Training.
• Release timely site regulatory documents and submit to the Clinical Trial Master File (CTMF).
• Submit weekly reports and monthly schedules.
• A Bachelor's degree in a health care or other scientific discipline or educational equivalent
• At least 1 year of on-site monitoring experience.
• Be proficient in computer skills, with direct working experience in multiple electronic platforms such as but not limited to: Share Rooms, Clinical Trial portals, Central IRB portals, Time reporting portals, Learning portals, Access Databases, Microsoft Excel, Microsoft Skype, Adobe Acrobat Professional and scanning software etc.
• Experience representing sponsor with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Drug Regulatory Affairs Group, Regulatory Document Review Group, Site Monitoring staff, other departments within Clinical Operations and if required clinical trial vendors.
• Knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Sponsor
• Proficient in documentation, including but not limited to invoices, time recording, schedule of monitoring visits and schedule of time off at the direction of the Executive Director (ED), Site Monitoring, Executive Director CSIM or designee.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
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