Senior Clinical Research Associate

TheSenior Clinical Research Associateis responsible for the overall operational execution of clinical studies on one or more clinical projects/programs; from study concept through study completion. This position will perform required job duties with guidance from Clinical Trial Managers to ensure that trial timelines, costs, and quality metrics are met, and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements helps design and execute clinical research activities. PRIMARY RESPONSIBILITIES: Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an EDC Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements Overseeing clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information Train CROs, vendors, investigators, and study coordin #J-18808-Ljbffr