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The Manager Clinical Research manages team members that work closely with study subjects and other research staff and supervises most steps of the research trial process to collect, compile, document, and analyze clinical research data. This position reviews research documentation, reports, and graphs while overseeing appropriate logs, the tracking of participants, and the preparation of study materials.
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Essential Job Function
Collaborates with key departments and leaders to accomplish strategic goals and objectives, fostering interdisciplinary teamwork and enhancing the hospital/medical group's reputation as a leader in a specific area of research.
Manages the daily operations of the Clinical Research program, ensuring adherence to standards for good clinical practice (GCP) and compliance with guidelines and regulations from the office of Human Research Protection (OHRP), the Food and Drug Administration (FDA), and local or central institutional review boards (IRB), maintaining the highest standards of ethical conduct in research.
Supports the growth and development of the research program, identifying opportunities for expansion, collaboration, and research excellence, and advocating for resources and support.
Supervises multiple clinical trials simultaneously or clinical trials, ensuring research activities are completed efficiently, optimal use of resources and timely execution of research protocols.
Reviews data collection of patient charts, medical records, interviews, and diagnostic tests, as well as reviews comprehensive documentation, ensuring the accurate and reliable analysis of research data.
Oversees the fiscal operations of the department, including preparing and managing departmental and pharmaceutical studies budgets, ensuring financial accountability and efficient resource allocation to support the successful execution of research projects.
Supports the growth and development of the Clinical Research program, identifying opportunities for expansion, collaboration, and research excellence, and advocating for resources and support to further advance oncology research within the hospital/medical group industry.
Performs other duties as assigned.
Education
Required: Bachelor's Degree
Experience
Required: 5-7 years, including direct experience as a Clinical Research Coordinator
Licensure/Certification/Listing
Required: Certification in clinical research or human subject research