Basic Function and Scope of the Position: Provides clinical support for diagnostic product development to achieve clearances and approvals in the US and internationally. Provides clinical trial site management and assures successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures. Reviews, assesses and interprets data from ongoing and completed studies. Conducts clinical compliance activities. May be responsible for multiple clinical studies. Tasks and Responsibilities: •Monitors the assigned clinical trials following company SOPs and in accordance with GCP, FDA regulations, and applicable international regulations concerning clinical trial activities. •Works with business development to contract external sites, as required. •Submits protocols and other documents to Institutional Review Boards / Ethics Committees with follow through to ensure successful outcome. •Assists in preparation of study-specific binders, logs and forms. •Participates in conference calls and meetings to review progress of ongoing clinical trials. •Reviews all unanticipated adverse device effects (UADEs), ensures medical review and reporting requirements are met, and that all company procedures are complied with. •Maintains project files including: ethics committee approvals; curricula vitae of investigators and study personnel; package insert, instructions for use, and user guides; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment. •Participates in the conduct of internal and external audits and inspections of clinical studies. •Participates in departmental planning sessions, and SOP development. •Coordinates shipment of clinical samples and manages transfer process of the resulting data when central laboratory facilities are used. •Tracks completed CRFs per monitoring and data management plans to ensure completed CRFs are rapidly entered into the database. Ensures that queries generated during data cleaning are responded to and resolved in a timely fashion. •Responsible for the day to day management of 3 or more clinical trial sites for 2 or more clinical trials. •Responsible for identifying potential investigators, gathering and analyzing information for investigator selection, and builds relationships with potential external clinical sites. •Responsible for identifying and preparing required materials for investigator start-up meetings. Organizes investigator start-up meetings. •Responsible for identifying and preparing trial-related documentation (study logs, forms, protocols, consent documents, letters of agreement, confidentiality agreements, etc.). •Plans the requirements for clinical trial material, orders clinical trial material, sets up and monitors the systems whereby the clinical project coordinator can ship clinical trial material to the investigator, maintains procedures to account for the clinical trial material, checks the expiration of clinical trial material and requests extensions if necessary. •Identifies and manages enrollment strategies to meet study requirements (e.g., ongoing investigator and study coordinator meetings, newsletters, advertising, etc.). •Evaluates clinical data/information and prepares reports as required. •May assist clinical project lead with basic project scheduling and budget planning. •Participates in writing monitoring plans in accordance with protocol requirements. •Acts as lead CRA for complex projects. •Mentors junior CRAs to promote departmental skill base. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.