Director, O’Neal Comprehensive Cancer Center Clinical Protocol Office
The Director is responsible for the development, implementation, and oversight of the administrative, financial and operational structure to support all clinical research activity within the Clinical Protocol Office (CPO). This role will support and work closely with the Disease Working Group Leaders of the Center. Ultimately supervises all CPO staff and works closely with senior staff members to plan, prioritize and implement operational goals. Ensures that all CPO staff have clearly performance standards, orientation, and continuing education. Establish appropriate quality control procedures to ensure compliance with federal, state, local, and institutional guidelines.
Principal Duties and Responsibilities:
• Provide operational leadership and effective management for the CPO.
• 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 O’Neal Cancer Center both nationally and internationally
• Assure compliance with the GCP, human subjects protection, and all regulatory agencies
• Build and maintain the appropriate infrastructure to support clinical trial related activities.
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 CPO operations and clinical research conduct in collaboration with the relevant Cancer Center and institutional managers.
• 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.
• Oversees QA functions for the clinical research operations; includes routine industry/FDA audits for data quality, regulatory compliance, and patient safety issues related to clinical trials.
• Ensure compliance with local, state, university and federal FDA regulatory standards
• 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 CPO core functions.
• Supervise the training/development and performance management for Research Study Assistants, Research Project Coordinators and Clinical Research Coordinators (direct and indirect reports).
• Develop and maintain the CPO budget.
· Bachelor's degree in related science required. RN, MD or PharmD preferred.
· 10 years or greater of related work experience in clinical research, preferably with a focus in oncology or other high-risk research specialty.
· 5 plus years of personnel management experience, with demonstrated ability to effectively lead a large and diverse staff.
· Must possess analytical experience to effectively represent large-scale, highly visible projects, present information in person and in writing and leverage resources and motivate staff.
· Must demonstrate strong understanding of policy and practice governing research compliance and possess the ability to operationalize evolving research policy (IRB, OHRP, DHHS) relating to human subjects research.
· Decision Making: Ability to make decisions with significant, broad implications for the management and operations of a major department or multiple departments. Participates in decisions on overall strategy and direction of the organization.
· Problem Solving: Ability to address problems that are broad, complex and abstract, often involving Medical Center-wide issues and requiring substantial creativity, resourcefulness, staff engagement, Lean diagnostic techniques, negotiation and diplomacy to develop solutions.
· Written Communications: Ability to communicate complex information effectively in writing to all levels of staff, management and external customers across functional areas.
· Oral Communications: Ability to verbally communicate complex concepts and address sensitive situations, resolve conflicts, negotiate, motivate and persuade others.
· Knowledge: Demonstrate a broad and comprehensive knowledge of theories, concepts, practices and policies with the ability to use them in complex and/or unprecedented situations across multiple functional areas.
· Team Work: Ability to lead collaborative teams for larger projects or groups both internal and external to the Medical Center and across functional areas. Results have implications for the management and operations of multiple areas of the organization.
· Customer Service: Ability to lead operational initiatives to meet or exceed customer service standards and expectations in assigned unit(s) and/or across multiple areas in a timely and respectful manner.
Please direct questions regarding the position to Mike Bertram, PhD, Associate Director for Administration:
To apply follow this link: https://uab.taleo.net/careersection/ext/jobdetail.ftl?job=T60114