SeniorClinicalTrialAssociate

**Position Summary:** The Senior Clinical Trial Associate (CTA) is a highly skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and helping lead the study team across all investigator sites. Based on experience, the Senior CTA assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the Senior CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The Senior CTA may act as a Clinical Research Associate with limited monitoring responsibilities. **Essential Job Functions and Responsibilities:** These may include but are not limited to: * Execute study activities independently according to study protocol, regulatory guidelines and operational plan * Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures * Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards * Contribute to study start-up, conduct, and closeout activities including, but not limited to, create patient facing materials, draft newsletters and site memos, track study metrics and escalate issues to study team Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines * Participate in vendor management activities by tracking performance and quality * Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes * Collect and review site regulatory