Clinical Research Coordinator I
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About The Position
Ann & Robert H. Lurie Children's Hospital of Chicago is seeking a dedicated individual to join our team in a role that supports our clinical research initiatives. This position is pivotal in ensuring that our research programs run smoothly and efficiently, with a focus on both patient-facing and data administrative responsibilities. Under direct supervision, the successful candidate will assist with study start-up processes and maintain all regulatory documents required by sponsors and regulatory agencies. This includes preparing protocols, informed consents, modifications, renewals, and other necessary documents for review by the Institutional Review Board (IRB) and/or sponsors. The role involves assisting clinical research personnel in the implementation of clinical research projects, which includes identifying and recruiting eligible study subjects, arranging study visits, and providing instructions to study participants and their families. The candidate will facilitate study initiation, monitoring, and close-out visits, and may also attend investigator meetings. Data management is a key component of this position, requiring the abstraction of data from medical records and entry of medical information onto protocol-specific case report forms (CRF) and other required study forms. The candidate will also assist in creating and updating case report forms and source document templates, coordinate reimbursement for subjects, and maintain an inventory of supplies and equipment. In addition, the role requires the preparation of lab kits and requisitions prior to visits, collection and processing of specimens from subjects, and recording data on source documents and CRFs or electronic web-based systems. The candidate will conduct literature searches, assist with quality assurance and quality control procedures, and monitor and report adverse events. Adherence to research protocols in compliance with applicable institutional, local, and federal regulations (OHRP, FDA, GCP, etc.) is essential. The candidate will also help triage patient questions and maintain all study documents, including regulatory binders and correspondence. Opportunities for professional development are encouraged, including attendance at relevant educational meetings and conferences. The position emphasizes a customer service focus, aiming for innovation, service excellence, and teamwork to provide the highest quality care and service to our patients.
