Cra Ii

Syneos Health · LVA-Remote · remote Syneos Health is seeking a CRA II to join their Clinical Solutions team. The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits. They will ensure regulatory, ICH-GCP, and protocol compliance, and maintain a working knowledge of ICH/GCP Guidelines and relevant regulations. Responsibilities: Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits Ensure regulatory, ICH-GCP, and protocol compliance Evaluate overall performance of site and site staff, and provide recommendations regarding site-specific actions Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site Conduct Source Document Review of appropriate site source documents and medical records Verify required clinical data entered in the case report form (CRF) is accurate and complete Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary Utilize available hardware and software to support the effective conduct of the clinical study data review and capture Verify site compliance with electronic data capture requirements Perform investigational product (IP) inventory, reconciliation, and reviews storage and security Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents Support subject/patient recruitment, retention, and awareness strategies Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution Understand project scope, budgets, and timelines, and manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met Act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions Qualifications: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Good computer skills and ability to embrace new technologies Excellent communication, presentation, and interpersonal skills Ability to manage required travel of up to 75% on a regular basis