• Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals • Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc. • Communicate scientific rationale for assigned studies to team members and clinical sites • Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements • Create/edit, distribute and collect site feasibility questionnaires • Oversee and support collection of essential documents during study start-up • Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution. • Collect study and site metrics and maintain study trackers, as needed • Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries • Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits • Partner with field CRAs and CTAs to resolve issues identified during site visits • Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions • Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues • Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor • Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors • Conduct remote monitoring tasks including reconciliation of site investigational product accountability • Provide data listings and compile clinical study report documents to support medical writing activities • Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations • Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate. • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.