Centralized Education and Training Services (CETS)Regina S. Cunningham, PhD, RN, AOCN The Centralized Education and Training Services (CETS) enhances the quality of clinical cancer research through the education and training of cancer research professionals practicing at CINJ and throughout the CINJ clinical research centers of the CINJ Oncology Group. The effective conduct of quality clinical cancer research requires highly competent clinical research personnel who must be knowledgeable about research methods, regulatory and compliance issues, biostatistics, and clinical trials management in the oncology-specific context. The increased complexity of trial design, the exponential increase in demands relative to regulatory issues, advances in informatics, and the need for patient protection make a compelling case for a more formal and systematic approach to the education and skill maintenance of clinical cancer research personnel. CETS provides a continual source of well qualified research professionals who supports CINJ's core mission of highly innovative, high quality translational discovery. Objectives The overarching goal of the CETS is to enhance the quality of cancer clinical research by educating and training new clinical research professionals by: providing ongoing education for established research professionals; identifying and disseminating evolving regulatory and compliance information; and imparting special knowledge about specific protocols among cancer research professionals. The CETS provides oncology-specific research education that is designed to ensure that research professionals are fully cognizant of their responsibilities in terms of patient safety, protocol compliance, data integrity, regulatory compliance, and careful quality control. The specific goals of this shared resource are:
Services Development of clinical oncology research education and training programs: The CETS staff work collaboratively to design program curricula, establish behavioral objectives, identify and secure appropriate faculty, and design program evaluations to educate and train new research personnel. A Curriculum Committee comprised of CETS members and other individuals involved in education or training of clinical research personnel, as well as clinical investigators meet quarterly to develop curricula. The committee develops the curricula based on needs assessments, planning committee input, CETS Advisory Committee recommendations, and new regulatory and compliance information. Development of clinical oncology research-specific continuing education programs: The CETS staff, likewise, work collaboratively to design continuing education program curricula, establish behavioral objectives, identify and secure appropriate faculty, and design program evaluations for continuing education. The curriculum for the continuing education program is based on needs assessments, planning committee input, CETS Advisory Committee recommendations, and new regulatory and compliance information. Program material production: For both aspects of the training, the CETS prepares and produces program materials including course syllabi and resources to assist in participant learning, such as copies of slides and faculty publications. Coordination of educational programs and meetings: The CETS Staff Assistant is responsible for coordinating the scheduling of all educational programs, securing program locations, audiovisual equipment, meals, public safety and housekeeping support, and parking availability. In addition, she arranges meetings of the CETS Advisory Committee and Curriculum Committee. Minutes of these meetings are maintained and disseminated by the CETS Staff Assistant. Assist the Office of Human Research Services (OHRS) Regulatory Affairs Services in dissemination of evolving regulatory and compliance information and incorporate these issues into education sessions. The Manager of the OHRS Regulatory Affairs Services is a member of the CETS. He is charged with staying abreast of evolving regulatory and/or compliance issues and is assisted in the task of disseminating this information by the CETS. Consultation with investigators to develop protocol-specific educational programs: The CETS works with Research Program Leaders and clinical investigators to develop protocol-specific education. This ensures that the research staff is fully knowledgeable about the nuances and complexities of specific protocols before protocol initiation. Many studies require coordination, not only with the clinical research-oriented shared resources such as the OHRS and the Research Pharmacy, but also with other shared resources, such as Tissue Retrieval and the Pharmacokinetics/ Pharmacodynamics Laboratory Shared Resource. Members of the CETS are responsible for ensuring that all research personnel involved in the trial can carry out the experiment in a knowledgeable and confident manner while maintaining protocol compliance. Provide ongoing safety and monitoring education: The CETS provides ongoing safety and monitoring education to clinical research staff in order to ensure compliance with the CINJ DMSP. Assistance with the development of research professional competencies: CETS staff works with the Director of OHRS to plan specialized learning opportunities for staff. The CETS Oncology Education Specialist works collaboratively to assess staff knowledge and establish plans to meet individual learning needs. The CETS Oncology Education Specialist works with OHRS staff and Research Pharmacy Shared (OES) Resource staff in the orientation of new clinical research employees. Coordination of clinical research training practicums for research professionals: The CETS OES collaborates with members of the CINJ Oncology Group to assist in the planning and implementation of educational experiences and establishes on-site clinical research practicums to meet the individualized learning needs of clinical research professionals. Communication of clinical research related activities: Each year, the CETS develops a calendar highlighting research educational activities and programs. This document is mailed to clinical research and cancer professionals throughout the State of New Jersey. Research educational needs assessments: OHRS is in frequent contact with the research centers of the CINJ Oncology Group. Education needs are determined and where possible, tailored for the institution. This is added to the CETS program. Other members within CINJ are surveyed periodically about adequacy of CETS activities and to ascertain additional educational needs. Contact: Regina S. Cunningham, PhD, RN, AOCN
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Shared Resources
Analytical Cytometry / Image Analysis Office of Human Research Services Centralized Education & Training Services Protein Structure Analysis and Modeling Pharmacokinetics / Pharmacodynamics New Jersey Family Medicine Research Network Survey Research and Qualitative Methods All the above Facilities are supported by CINJ’s Cancer Center Support Grant (CCSG)
Additional Shared Resources
Rutgers Center for Operations Research Rutgers University Cell & DNA Repository The Environmental and Occupational Health Sciences Institute (EOHSI) Center for Advanced Biotechnology and Medicine (CABM) Laboratory for Cancer Research Biotechnology Center for Agriculture and the Environment Institute for Advanced Study (IAS)
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