Assistant Director CTO Quality Assurance - 136130

The Quality Assurance (QA) Program is integral to the quality oversight activities of the Moores Cancer Center (MCC) Clinical Trials Office (CTO). This position manages operations, including administrative and budget operations, for the clinical research quality assurance program within the CTO, ensuring alignment with departmental goals and institutional priorities.

Reporting to the MCC CTO Senior Administrative Director, the Assistant Director of QA receives overarching research and operational objectives and defines subordinate goals to achieve those objectives. The Assistant Director is responsible for building and advancing a scalable QA infrastructure that supports high-impact oncology research, including investigator-initiated trials (IITs), industry-sponsored trials, and cooperative group studies.

This role leads transformational efforts in QA, including strategy development, systems implementation, external regulatory inspection readiness (including FDA audits), and the integration of quality measures throughout the clinical trial lifecycle. The position establishes and oversees an internal MCC CTO QA Team composed of auditor/monitors, capable of evaluating clinical, regulatory, investigational product, data, and laboratory components.

The Assistant Director partners closely with the CTO Medical Director, Disease Team Leaders, Regulatory Affairs, the Data and Safety Monitoring Committee (DSMC), and institutional leadership to develop and implement quality frameworks that meet or exceed internal expectations and external regulatory standards. As a recognized expert in cancer clinical trial quality assurance, this individual applies advanced knowledge of clinical research protocols and processes to ensure rigorous, high-quality research conduct across MCC trials.

Manages operations, including administrative and budget operations, for a clinical research initiative or clinical research program. Receives research objectives and defines subordinate goals in order to achieve those objectives.

• Advanced degree in related area and/or equivalent experience/training.

• Seven (7) or more years of relevant experience.

• Broad academic knowledge and applied background in clinical research philosophy. Applies knowledge of theoretical concepts and business best practices in a trial setting. Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical trials.

• Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.

• Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues.

• Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations. Effectively manages multiple important priorities.

• Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade.

• Demonstrates excellent problem-solving and analytical skills. Creatively addresses complex or new problems. Proven skills to quickly evaluate complex issues and identify multiple options for resolution.

• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings.

• Demonstrated ability to organize research work functions in an efficient and effective manner. Great organizational skills applied to personal work and improving organization of assigned staff and trial.

• Expert user of the campus' clinical information and documentation application programs. Technical proficiency in project management software.

• Experience within the UC System.

• Must be able to work various hours and locations based on business needs.

• Employment is subject to a criminal background check.