Job Abstract

The mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

Position Summary:

This position is focused on the development of department clinical research strategies and implementation of current/new clinical research programs. The qualified individual will partner with faculty researchers and their teams in the Department of Radiation Oncology (RO), and other divisional and department leaders and administrators, as needed and appropriate. As the Administrative Director, you will play a critical role in supporting the planning, maintenance, and reporting out of our clinical research activities. The individual will direct teams (regulatory and compliance, clinical research, and data management) to provide administrative, financial, and clinical support for research activities throughout RO.

Candidates will demonstrate knowledge of clinical research deliverables and how research activities impact financial transactions (such as payment invoice triggers and research procedure charges) and personnel effort allocation. Successful candidates will demonstrate LEADing Self qualities in their interactions with direct reports, peers, colleagues and other stakeholders.

Applicants to this position will utilize knowledge regarding the activities and guidelines award life cycle management as well as knowledge of institutional departments, data systems, and processes that facilitate pre and post award activities.

Key Responsibilities:

Pre-Award Research Development and Planning

· Partners with faculty, research personnel, and administrators on assessing project feasibility for the submission of research proposals to various funding agencies

· Review research contracts and budgets to identify project deliverables and payment triggers; meet with project personnel to identify met deliverables and milestones

· Oversee the assessment of project effort and resource needs and assignment of personnel

· Prepare and/or submit documents necessary for setup of funding accounts or other accounts needed to facilitate research activities

· Oversee protocol submissions to IRB (or equivalent regulatory body) to ensure timely response and actions by radiation oncology personnel; develop strategies and workflows to align protocol activation timelines with institutional goals

Research Implementation

· Oversee scheduling of study activation meetings and other project kickoff meetings

· Oversee radiation oncology research personnel operations to ensure accomplishment of project deliverables; identify issues and work with faculty and stakeholders to recommend improvements and appropriate escalation measures

· Oversee the implementation of educational and or training initiatives to ensure personnel compliance with department, institutional, industry, and or regulatory standards and practices

· Oversee the development and revision of standard operation procedures guiding research administration in radiation oncology

· Develop tracking systems to follow key performance metrics relevant to research administration

· Develop and maintain effort allocation tracking documentation of research personnel

· Review and update personnel effort in collaboration with department stakeholders

· Review and update project end dates in collaboration with department and extra-institutional stakeholders.

· Oversee preparation and submission of project payment milestone invoices

· Partners with department and divisional administrators on the review and reconciliation of charge captures to research accounts

· Oversee initiation of study close out processes

Strategic Planning, Reporting and Workflow Optimization

· Generate reports for management, highlighting key performance indicators to support strategic decision-making by leadership (data management; protocol management; accrual management; safety reporting; compliance tracking; ect..).

· Work closely with operational teams to ensure tracking and reporting of study activity.

· Assist in the development of models for new proposals and business activities.

· Support internal and external audits by providing accurate and timely information and documentation.

· Assist in the development of models to evaluate the impact of different clinical trial scenarios, providing valuable insights to support business decisions.

· Collaborate with cross-functional teams, providing assessment and analysis of research activity to drive informed decision-making and optimize project performance

· Identify workflow improvements and make recommendations to optimize processes

Cross-Functional Collaboration:

· Collaborate with stakeholders (internal and external to RO) representing business operations, research conduct, compliance, human resources and so forth to identify needs and provide relevant insights & information

· Actively participate in cross-functional teams to drive process improvements and enhance project performance and or compliance

· Train and educate department stakeholders in best practices and procedures in the implementation transactions

· Liaise with institutional and departmental offices overseeing research operations to ensure RO compliance with policies, regulatory requirements, and industry standards.

Personnel Management

· Creates a safe environment that encourages and supports self-development and learning for all personnel through initial orientation, regular feedback, ongoing development, training programs, work experiences, and assessing competencies

· Assess employee performance; liaises with Human Resources to plan best course of action is followed by RO

· Cascade information and communication from Division Leadership in a consistent and timely manner throughout reporting structure

· Other duties as assigned

Key Responsibilities

The Administrative Director of Protocol Research will be responsible for:

· Developing, implementing, and updating research protocols in collaboration with relevant departments.

· Ensuring compliance with regulatory requirements and ethical standards.

· Conducting regular audits to assess protocol adherence and identifying areas for improvement.

· Collaborating with the IRB and other regulatory bodies to facilitate approvals and address concerns.

· Providing guidance and training to research staff on protocol-related matters.

· Serving as a liaison between research teams and external stakeholders in matters related to protocols.

Anticipated Benefits:

· Improved research efficiency and data quality.

· Enhanced reputation for adherence to ethical and regulatory standards.

· Reduced risks associated with research activities.

· Increased collaboration and communication across departments.

In conclusion, the creation of the Administrative Director of Protocol Research is a strategic move to elevate the standard of our research practices, ensure compliance with ethical and regulatory standards, and enhance the overall success of our organization. I am confident that this position will prove instrumental in achieving our research objectives and maintaining the highest standards of excellence.