Director, Cancer Center Clinical Trials Office
Position number 00007755Job opening # 9341
Responsibilities
This position will serve as Director for the GRU Cancer Center Clinical Trial Office (CTO), which includes
the Phase I Clinical Trials Unit and the Protocol and Review Monitoring System (PRMS) of the Cancer
Center.
The duties include, but are not limited to: providing oversight of clinical research activities, ensuring
compliance with established federal, state, local and institutional guidelines governing the conduct of
clinical research; implementing processes and procedures to improve compliance and the programmatic
and fiscal integrity of the clinical research activities; effectively communicating with the GRU Cancer
Center Director and Associate Center Directors, investigators, research staff, and representatives of
study sponsors to facilitate the research activities; coordinating the work and responsibilities of research
staff; analyzing study protocols, contracts, and budgets; coordinating, evaluating, and following patient
participation in clinical trials; developing strategies for patient recruitment, compliance, and
maintenance; serving as liaison for internal and external vendors; conducting presentations to sponsors
and organizations; participating in meetings and task forces pertinent to conducting oncology research.
Other duties also include coordinating with the sponsoring pharmaceutical and biotechnology
companies in: a) implementation of clinical trials; b) safety data collection and reporting; c) supervision
of trial related sample collection and shipping; and d) assisting Clinical Trials Office to create budgets for
the activities performed in the GRU Cancer Center. This position is also responsible for promoting a
customer friendly environment and providing superior service to our patients, students, faculty, and
employees.
Principal Duties and Responsibilities:
Leadership
• Provide operational leadership and effective management for the GRU Cancer Center
Clinical Trials Office (CTO), including community–based partners, consortia members and
outreach clinics.
•
Responsible for coordinating all aspects of clinical research operations at the Cancer Center
to assure that high quality and ethical clinical research is conducted within an environment
that facilitates clinical research and that will enhance the scientific reputation of the Cancer
Center both nationally and internationally
•
Manage the expansion of clinical research activities to satellite sites and affiliates
•
Oversee the structure and processes of the PRMS and DSMP with the support of the
assistant directors, managers and committee administrators
•
Assure compliance with the GCP, human subjects’ protection, and all regulatory agencies
Clinical Trials Program Oversight
• Develop, implement, and update SOPs to ensure consistent, safe and efficient management
of clinical trials and the subjects enrolled.
•
Provide oversight over clinical research informatics matters related to CTO operations and
clinical research conduct in collaboration with the relevant Cancer Center and institutional
managers. Provide direct supervision of the Cancer ONCORE team.
•
Ensure quality, timely, accurate data submission. Develop quality control mechanisms and
systems for the management of data.
•
Generate protocol status reports for key stakeholders including Principal Investigators,
leadership, clinical teams, institutional review board etc. Provide oversight for monthly
reports about accrual, monitoring and audit visits. Provide oversight and guidance for
monthly reports of income from industry sponsored trials as well as grants. Accountable for
accuracy of trial information in all trial databases and tracking systems.
•
Lead QA functions for the clinical research operations; participate in routine audits for data
quality, regulatory compliance, patient safety issues related to clinical trials, etc.
•
Actively work to address quality improvement opportunities.
•
Incorporate a patient centered approach that consciously includes the patient and family’s
perspective and focuses on needs as they define them.
Staff Management
• Responsible for appropriate staffing and skill to adequately administer the CTO core
functions.
•
Supervise the training/development and performance management for Research Study
Assistants, Research Project Coordinators and Clinical Research Coordinators (direct and
indirect reports). Responsible for the hiring of new staff.
•
Develop and implement strategies to continuously improve employee engagement.
•
Collaborate closely with Associate Director for Clinical Investigations, chair(s) of the protocol
review and monitoring systems (PRMS) and committee(s) to assure the ultimate success of
clinical research programs.
•
Keep abreast of current state-of-the-art developments relating to clinical trials and provide
education to clinical staff and other team members.
•
Participate in conferences, scientific meetings, and writing of abstracts.
Minimum Required
Master’s degree from an accredited college or university with a minimum of five years relevant
experience; previous supervisory experience, or a Bachelor’s degree from an accredited college or
university supplemented by eight years relevant experience; demonstrated comprehensive skills and
training in clinical research and business administration to include financial management, personnel
administration, program planning, development, and implementation. Working knowledge of FDA
regulations governing clinical research, Good Clinical practices, and OHRP regulations; ability to
develop/manage databases and learn/ train others on new applications and web-based programs;
excellent interpersonal and verbal/written communication skills.
Preferred
Ph.D. or completion of course work towards Ph.D.; RN with two years management and three years
oncology clinical research experience; previous experience coordinating and managing oncology clinical
research programs, especially in an academic medical center setting; proficiency in Excel and
PowerPoint. The Cancer Center promotes a tobacco free environment; the selected candidate is
preferred to be a non-smoker.
Please apply at http://www.gru.edu/jobs/university/external.php to job opening 9341.