DescriptionClinical Research Coordination * Handles an increased volume of studies / patients on study * Assigned studies of increased complexity * Independently identifies issues and proactively troubleshoots with investigators, sponsors and internal partners to ensure they are addressed. * Analyzes problems / issues of moderately complex scope and determines solutions * Coordinates research studies, including proactive identification of participants and supporting the PI in determining patient eligibility with limited guidance. * Coordinate research studies, identify participants according the IRB approved recruitment plan and assist the PI with determining patient eligibility. * Facilitate the informed consent process, communicate protocol requirements to the participant, provide participant education related to protocol requirements and the significance of protocol compliance. * Complete, organize and maintains all documentation required by the Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Good Clinical Practice (GCP) Guidelines, or the funding source. * Manages patient registration, data and treatment assignment. * Participates in quality control and quality assurance activities related to study workflows and documentation. * Procure and distribute required study supplies to the appropriate sites for study start-up and ongoing study needs. Including Coordination of specimen collection & shipping biospecimens. * Facilitate the safe and accurate completion of protocol required procedures in accordance with FDA CFR, GCP, and institutional best practice. * Collect information for adverse event (AE) or serious adverse event (SAE) reporting to review with the Investigator and facilitates reporting requirements to applicable stakeholders (DSMB, IRB, funding source). Data & Regulatory Management * Assist in developing the study informed consent form(s) and amending the informed consent form(s) as applicable. * Prepare and submit site or study-specific regulatory documents. * Track and maintain required case histories/ essential documents as defined by FDA CFR and GCP to ensure regulatory compliance. Assist with routine and audits performed by internal review committees and/or external stakeholders. * Ensure timely regulatory reporting and thorough documentation. * Develops and implements adequate Corrective and Preventative Action (CAPA) plans as needed. Training and Development * Completes role-based training and occupational training as applicable, e.g. blood borne pathogens, infection control, hand hygiene, donning and doffing PPE. * Attend study initiation meetings, and participate in team and general staff training events (i.e., teleconferences, webcasts, and/or meetings). * Completes protocol required training as needed. Service Excellence * Provide ongoing communication to all stakeholders to ensure pertinent information is disseminated. * Timely response to and resolution of inquiries, both written and verbal, with the appropriate level of information for the request. * Maintain a service centered approach for both internal and external customers, ensuring a high level of quality, communication, and support. Other Duties as Assigned * This position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change.