The Center for Inherited Blood Disorders (CIBD) is a mission-driven non-profit focused on delivering high-quality, comprehensive, and family-centered care to improve the quality of life for children and adults with blood disorders. When choosing a career with CIBD, you will be part of a growing organization dedicated to improving public health and committed to your professional development. Job Summary The Clinical Research Coordinator II (CRC II) is responsible for coordinating clinical studies in accordance with Institutional policy, Good Clinical Practice, and International Council for Harmonization (ICH) guidelines, as adopted by the Food and Drug Administration (FDA). The CRC II manages moderate complexity trials and assignments will be adjusted gradually to add increased responsibility based on demonstrated competency. The CRC II follows and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. The CRC II will attend clinic as needed to perform activities including, but not limited to: assisting in recruitment activities, administering questionnaires, answering questions regarding future appointments, and randomizing patients to study. The CRC II also creates and maintains the research record for the compilation, registration and submission of data, as required by Sponsor. Essential Job Duties Ensures protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried our per protocol requirements. Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary documents. Manages the collection of significant information and data, ensures that it is precise and accurate, and monitoring it throughout duration of the study. Fulfills sponsor requirements, while optimizing the safety of research subjects, by monitoring and reporting important information, including: adverse events, unanticipated problems, and other information required by the sponsor protocol. Assembles lab kits and other supplies in preparation to obtain required bio-specimen samples and ships samples externally according to International Air Transport Association (IATA) requirements, to appropriate laboratories for processing. Requirements AA or equivalent additional experience (BS preferred) Minimum of 3 years clinical research experience Prior experience coordinating investigational drugs studies Licensure/Certification Basic Life Support
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