The Clinical Research Coordinator will be responsible for all aspects of clinical trials in the Division of Urology at John H. Stroger, Jr. Hospital of Cook County Health. As part of a multidisciplinary project team, the Clinical Research Coordinator will manage and direct the coordination and timely handling of all components of clinical research protocols, including pre and post research activities, in and outside the clinical setting. Clinical Research Coordinator will be responsible for the implementation and conduct of multiple research projects, including clinical phases (I-IV), development of effective patient recruitment strategies, coordination of comprehensive patient protocol treatment schedules, and overseeing and participating in subject recruitment, screening, scheduling, testing, and data management for multi-faceted investigation.
Assist in the establishment and coordinate the implementation of clinical research protocol priorities and organizational structure.
Notify and inform physicians, clinical staff, affiliates, and grant sponsors of adverse events and protocol modifications, including their impact on the clinical research and patients enrolled at CCH.
Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the CCH Institutional Review Board (IRB) and study sponsors.
Review laboratory and clinic procedures and evaluations regularly to ensure protocol compliance.
Act as a liaison between physicians, clinical staff and the CCH IRB office, sponsors, and regulatory agencies to ensure priorities are clearly communicated and resources are allocated appropriately across multiple ongoing projects.
Assist physicians and clinical staff in the identification, recruitment and enrollment strategies of patients to increase enrollment and to meet clinical research protocol requirements.
Execute informed consent process and monitor patient status; enroll patients into research studies, explain the studies to the patients and their families/loved ones.
Ensure that the patient enrollment and research activities comply with the established protocols, regulatory and monitoring agency standards, and sponsor guidelines.
Participate in conducting surveys and quality of life interviews of patients in research protocols.
Bachelor’s degree in nursing, health science, or a health-related field required.
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional certification preferred and required within 2 years of hire.
At least one year experience in a clinical research setting and experience working with oncology clinical trials preferred.
Knowledge of current Federal Regulations and IRB’s required.
Ability to manage multiple tasks. Strong interpersonal and customer service skills. Requires excellent written and oral communications, presentation and computer/pc skills. Proficiency in Microsoft Office and other related software.
Knowledge of Medicare Coverage Analyses and conventional care cost billing, highly desirable.
Experience with Electronic Medical Records, a plus.
Knowledge of research protocols, principles and procedures; knowledge of aspects of clinical trials such as screening, interviewing, case report forms; knowledge of experimental design, statistics, computerized information retrieval systems, and computer data management; ability to identify, produce, organized, evaluate and interpret data; knowledge of ethics and regulatory procedures (e.g., informed consent process, data safety and monitoring plans, principles of data collection and documentation) involved with clinical trials and other clinical research; ability to work as a member of a project team; knowledge of clinical tasks required for research (e.g., phlebotomy, centrifugation, aliquoting blood, interviewing).