FSP Senior Clinical Research Associate

Overview Responsibilities include monitoring activities for assigned clinical sites, both in person and remote, including planning and execution of visits, and ensuring monitoring reports are written and completed in alignment with SOPs and local regulatory parameters. Responsibilities Conduct all types of monitoring and co-monitoring visits for assigned clinical sites, including site initiation, interim and close-out visits, and related monitoring activities. Prepare, review, and ensure completion of monitoring reports within required SOPs and local regulatory parameters. Ex-US: Potentially perform study startup activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site setup activities. Support development of study-specific monitoring documentation, including monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets; oversee site personnel management and training on protocol requirements, proper source documentation procedures, and case report completion requirements. Review source documents and case report forms for accuracy, completeness, and data integrity; identify and resolve ongoing data issues. Manage, prepare, send, track, and return investigational supplies; monitor and document dispensing, inventory, and reconciliation of supplies. Monitor assigned clinical trials and sites by reviewing enrollment and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities, and other activities contributing to proper trial conduct per protocol and regulatory requirements. Review and oversee regulatory documentation for accuracy and completeness; support sites with regulatory concerns as appropriate. Communicate with assigned clinical sites, investigators, site personnel, client personnel, and cross-functional team members to address study needs related to monitoring and site management. Participate in meetings and conference calls with internal project teams, Sponsor teams, and external partners involved in execution of the trial. Other duties as assigned. Necessary Skills and Abilities Excellent verbal, written, interpersonal, and presentation skills. Excellent computer skills with Microsoft Office (Outlook, Word, Excel, and PowerPoint) to prepare charts, tables, forms, reports, and presentations. Electronic data capture (EDC), CTMS, IVRS, and eTMF experience required. Knowledge of applicable local law, regulatory requirements, ICH Guidelines, and GCPs governing the conduct of clinical trials. Ability to prioritize tasks, plan proactively, and accomplish goals with minimal supervision. Ability to offer solutions when obstacles are identified and train as necessary to achieve project goals. General understanding of routine project goals from an organizational perspective. Strong organizational skills and attention to detail; ability to prioritize and plan workload. Educational Requirements Bachelor\'s degree or equivalent combination of education and experience. Experience Requirements > 5 years of experience as a Clinical Research Associate. #J-18808-Ljbffr ProPharma