Clinical Trial Specialist
Raleigh, North Carolina, Us
• Recruited and evaluated potential sites for project participation, utilizing assessment tools and questionnaires to obtain project-required information• Owned activation and management of assigned sites to ensure adherence to protocol design and proactively coordinated and driven completion of all requirements with urgency and professionalism, including but not limited to coordinating all process contributors, escalating status and risks with mitigation plans, leveraging tools and dashboards to monitor timeliness and quality of activation critical path, and meeting high-quality documentation requirements• Performed essential document collection, review, maintenance, submission, notification, and close-out activities, including but not limited to informed consent form (ICF) template(s), ensuring client and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines, and PRA SOPs• Performed project tracking to ensure clinical and site management information, including but not limited to project files, site contacts, client communications, and training assignments, are current, accurate, complete, and audit-ready• Liaison with internal and external stakeholders to meet project-specific goals, prepares for and participate in investigator and client meetings as necessary, escalate project and site-related issues per PRA SOPs, ensure client and investigator obligations are being met and are compliant with local regulatory requirements and ICH-GCP guidelines• Managed additional clinical operations and project management tasks as required and outlined in the job task list
