The Clinical Trial Specialist (CTS) supports moderately complex clinical trial activities. The CTS works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The CTS assists with vendor oversight and management. Identifies issues in a timely manner and escalates to management as appropriate. The CTS may complete monitoring visit report review and/or perform on-site monitoring. The core duties and responsibilities of the CTS are delineated below.
• Manages Site Essential Documents review during study start-up, maintenance and close-out period
• Prepares study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
• Ensures tracking of essential documents are received and filed in the CTMF, reviews site documents (including site-specific informed consent forms)for accuracy and follows up as needed
• Ensures tracking of patient status throughout the study at investigative sites
• Provides clinical team support with CTMF filing and management
• Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
• May review and approve trip reports, track data query reports, site visit metrics, and overall site performance
• May perform routine monitoring at limited clinical sites
• May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs
• Assists in the preparation of, and may present at investigator vendor meetings and workshops
• Actively involved in the performance of study feasibility assessments
• Adheres to study timelines, quality, and budget for assigned studies
• Provides rapid action to address both internal and site QA findings from audits
• May coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
• Routinely participates in department and clinical trial team meetings and may participate in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)
• Bachelors’ degree or higher
• 4 years industry experience preferred, in a scientific or medical field, with at least 2 years working specifically on clinical trial coordination and site management
• Previous Site monitoring experience
• Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
• Basic knowledge of therapeutic area or disease
• Understanding of study phases and general knowledge of how they apply to clinical development
• Advanced knowledge of Word, Excel, and PowerPoint.
• Knowledge of the principles and practices of computer applications in database management
• High degree of customer focus towards internal and external stakeholders.
• Strong interpersonal and collaboration skills.
• Strong verbal and written communication skills required.
• Able to handle multiple tasks and deadlines.
• Ability to identify issues and take appropriate actions.
• 10-30% travel may be required