The Clinical Trials Office of Loyola University’s Cardinal Bernardin Cancer Center supports the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention, screening diagnosis and treatment. Based in Maywood, IL (~10 miles west of downtown Chicago) on Loyola University of Chicago’s Health Sciences campus, our fully integrated research and clinical care teams in the Cancer Center seek to discover new cures for the world’s deadliest diseases and make life beyond cancer a reality.
The Cancer Center Clinical Trial’s Office (CC CTO) is currently recruiting CC CTO Manager. This position directs the planning, coordination, and management of the clinical trial activities and operations of the Cardinal Bernardin Cancer Center CTO. This includes administrative and fiscal oversight, regulatory compliance, staff training, support of programs, and direction for processes and communications. This position is responsible for oversight of clinical research activities within the disease teams, managing approximately 18-22 employees in the overall conduct of clinical trials, and for tracking and complying with clinical trial performance benchmarks, patient safety, staff training and development, and financial objectives.
This fast-paced and highly intense research environment requires management of complex clinical research studies involving a very vulnerable and sick population. The CC CTO Manager is responsible for ensuring the research team creates a caring and compassionate patient focused experience for the clinical research participants.
Responsibilities include:
· Staff recruitment in collaboration with Human Resources, CCTO Medical Director, Cancer Center Assoc Director of Administration, staff and the multidisciplinary team as appropriate.
· Develop, facilitate and support staff onboarding and development, including orientation, staff competencies, in-services, continuing education, staff meetings, etc.
· Direct and supervise the activity of research nurses, clinical research coordinators and regulatory coordinators.
· Ensure that operations, systems and processes are streamlined to provide seamless, ethical, efficient delivery of clinical research. Develop standard operating procedures as they relate to conduct of clinical research and are congruent with federal regulations.
· Ensure that staff is educated and compliant with procedures. Identify and address opportunities for improvement, implementing change through the utilization of research and quality improvement principles.
· Manage support for clinical trials across the life cycle of the study, including study feasibility, initiation, operation, and close out. Receive and review invitations for research studies from industry sponsors, cooperative group agreements, investigator-initiated trials (IITs) and Clinical Research Organizations (CRO). Consult, advise and meet with investigators for conducting clinical trials and assisting with development of protocols.
· Oversee clinical coordination of oncology clinical trials to ensure studies are completed on time, within budget and in compliance with the clinical trial protocol, standard operating procedures, FDA regulations and ICH/GCP guidelines. Ensure that the safety and welfare of human subjects are protected and that legal, privacy, and confidentiality measures are implemented.
· Participate in the evaluation and development of goals and priorities for the Cancer Center Research Program that is consistent with the Health System’s mission and strategic goals. Supports the research goals of the medical faculty to include planning, providing resources and training as necessary.
· Ensure compliance in our role as an NCI sponsored Cooperative Group multi-institutional sponsor. Oversight of affiliate network institutions to include development, implementation of a formal affiliate program that involves active, regular communication, auditing and training as required. Ensure compliance with data reporting requirements. Develop efficient systems to ensure timely completion and quality data.
· Ensure all aspects of Regulatory Compliance: Coordinate the Protocol Review and approval process for all cancer clinical trials; Coordinate the Data Safety Monitoring Committee (DSMC) and collaborate with the committee to develop processes to ensure regulatory compliance; Member of the DSMC; Oversight and coordination of NCI sponsored Quality Assurance Audits; Monitor federal, state and institutional requirements and regulations and ensure policies comply with requirements; Collaborate with the Institutional Review Board, Office of Research Services, Corporate Compliance and cooperative groups in ensuring regulatory compliance.
· Performs related duties as required.
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