Assistant Director, Clinical Research Training

Job Description

UW Medicine works to improve the health of the public by advancing medical knowledge providing outstanding primary and specialty medical care to people of the region and preparing tomorrows physicians scientists and other health professionals. Within the large UW Medicine health system the School of Medicine (SoM) is a world leader in biomedical research with the largest biomedical research program at a public university based on National Institutes of Health funding and ranking among the top research universities internationally.

The Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SoMs Office of Research and Graduate Education charged with providing multi-service support to clinical researchers bringing important new therapies to our patients in compliance with evolving regulatory requirements.

POSITION SUMMARY

Reporting to the CTO Senior Director theAssistant Director Clinical Research Training (Assistant Director)serves as a key leader providing strategic direction oversight and innovation in developing managing and budgeting for comprehensive training programs for faculty and staff engaged in clinical research across UW Medicine.

The Assistant Director oversees educational programs that span theentire scope of clinical research operations including trial start-up study management regulatory compliance financial operations and billing practices. The Assistant Director is responsible for developing and adhering to the operating budget for the training programs partnering with the Senior Director and CTO Financial Analyst to finalize as part of the larger CTO annual operating budget.

The Assistant Director ensures all personnel engaged in clinical research at UW Medicine are equipped with the tools and resources necessary to conduct studies with excellence efficiency and strict adherence to federal regulations institutional policies and sponsor requirements. This role balances strategic vision and training program management while fostering a culture of continuous improvement collaboration and compliance.

POSITION COMPLEXITIES

The Assistant Director balances institution-wide strategic leadership with the nuanced operational realities of diverse research environments across UW Medicine. Designing and executing a comprehensive training strategy that aligns with compliance requirements and workforce development goals demands high-level coordination between leadership regulatory stakeholders and operational units. This position must navigate differences in departmental priorities existing processes and readiness levels while ensuring consistent integration of training into onboarding career pathways and quality improvement initiatives. This work is compounded by the need to continuously monitor industry trends regulatory updates and technological advancements to adapt programs in real timerequiring a blend of visionary planning and ability to shift direction. Presenting data-driven recommendations to senior committees while anticipating the impact of upcoming policy shifts or budget changes adds further strategic sophistication to the role.

Equally challenging is the operational responsibility of developing and applying the operating budget while creating and overseeing multi-modal learner-centered programs that support clinical research from start-up through close-out. This involves combining adult learning principles with compliance-driven requirements while customizing materials for a wide range of roles and expertise levels. This role must manage program priorities within a defined budget in a shifting environment. The Assistant Director must coordinate contributions from subject matter experts manage diverse instructional formats ensure accurate reflection of evolving FDA cGCP cGMP NIH and CMS guidelines and address gaps through targeted remediation. Success depends on building strong collaborative networks across internal departments and external partners leveraging shared resources to enhance curriculum relevance and efficiency. Additionally the continual assessment of program impact through competency checks feedback and regulatory outcomesand subsequent rapid adaptation of contentrequires exceptional analytical communication and change management skills.

POSITION DIMENSIONS AND IMPACT TO THE UNIVERSITY

The Clinical Trials Office is a central clinical research operation with compliance responsibilities and services across the vast portfolio of clinical trials in UW Medicine. The CTO operation has direct impact on trial start-up timelines and UW reputation with major global biotech and biopharma sponsors and the availability of funded clinical trial opportunities in the UW addition the CTO plays a key role in mitigating institutional financial and reputational risks by ensuring strict compliance with the CMS and the FDA regulations and guidelines.

The Assistant Director is central to UW Medicines ability to maintain regulatory compliance operational excellence and a skilled workforce. By overseeing budgeting and training across the full clinical research lifecycle this role directly supports the institutions mission to advance medical discovery improve patient care and uphold the highest standards of research integrity while ensuring compliance with all rules and regulations.

DUTIES AND RESPONSIBILITIES

Strategic Leadership - 35%

• Design and execute a comprehensive UW Medicine-wide clinical research training strategy aligned with institutional priorities compliance requirements and workforce development goals.
• Lead the development of a role-based training requirement matrix and training tracking systems to ensure completion and compliance.
• Integrate training delivery into onboarding career pathway development and quality improvement initiatives across all departments engaged in research.
• Regularly evaluate program effectiveness through participant feedback performance metrics and compliance outcomes.
• Present findings and recommendations to the CTO Senior Director Strategic Leadership Committee and other UW Medicine leadership committees on training needs regulatory readiness and operational efficiency.
• Stay current on industry trends innovations in training technology and evolving regulatory landscapes.

Program Development Budget & Oversight - 30%

• Oversee develop and adhere to the annual operating budget for clinical research training programs. Partner with CTO Senior Director and Financial Analyst on finalizing the proposed operating budget.
• Oversee training programs financial performance including programatic costs vendor pricing assessments potential charge-back and revenue streams.
• Track and report to leadership on programs financial performance and offer solutions to any financial issues.
• Direct the creation of learner-centered training programs for web-based hybrid and classroom delivery.
• Develop and disseminate standardized tools templates and job aids to support all operational phases of clinical research from start-up to close-out.
• Incorporate adult learning principles diverse instructional methods and feedback-driven improvements into all educational offerings.
• Supervise training specialists instructional designers and administrative support personnel; coordinate and oversee the contributions of subject matter experts engaged in curriculum development and delivery.

Training Delivery & Assessment - 25%

• Oversee and deliver foundational specialty and advanced training sessions to faculty coordinators and other research professionals.
• Implement competency checks knowledge inventories and periodic training needs assessments.
• Monitor and evaluate learning outcomes; adjust content and delivery methods to address gaps and emerging operational or regulatory issues.
• Ensure training reflects current FDA cGCP cGMP NIH CMS billing rules and institutional guidelines.
• Communicate timely regulatory changes and operational updates to research teams through multiple channels including presentations workshops and reference materials.

Stakeholder Engagement - 10%

• Build and maintain a network of internal and external subject matter experts to enrich curriculum and provide training facilitation.
• Collaborate with the UW Institute of Translational Health Sciences (ITHS) regulatory offices research administration and external partners to leverage resources and share best practices.

MINIMUM REQUIREMENTS

• Bachelors degree in Clinical Research Health Administration Science Business Administration or related field plus at least six years of experience with clinical research training program development and administration

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements such as a license/certification/registration.

Additional Requirements.

• Current ACRP or SOCRA certification or completion within 6 months of hiring
• Demonstrated experience in clinical research management both investigator and industry initiated
• Record of delivering training across diverse multi-disciplinary audiences
• Advanced knowledge of FDA GCP NIH OHRP CMS and other regulations
• Demonstrated team leadership skills. Ability to make positive contributions and work effectively and efficiently in a team setting
• The ability to rise above the day-to-day operations and see the big picture the vision and the mission of the organization
• Excellent written communication skills to draft complex training content and materials
• Outstanding verbal and interpersonal communication skills to be able to interact effectively at all levels of leadership including with faculty staff sponsors vendors and clients
• Ability to work independently with a high degree of reliability accuracy and productivity
• Ability to handle confidential information responsibly
• Demonstrated ability to maintain harmonious working relationships and effectively address complex and sensitive administrative issues
• Proven track record in exercising discretion and independent judgment effectively in decision-making processes
• Demonstrated experience of successful handling of multiple projects with critical deadlines

DESIRED QUALIFICATIONS

• At least 5 years of management experience working in an academic medical center or a clinical research organization
• Advanced degree in Healthcare Business or Public Administration Finance or Clinical Research preferred
• Senior-level leadership experience in developing curricula for complex institutions

Compensation Benefits and Position Details

Pay Range Minimum:

Pay Range Maximum:

Other Compensation:

Benefits:

Temporary or Regular

FTE (Full-Time Equivalent):

Union/Bargaining Unit:

About the UW

Working at the University of Washington provides a unique opportunity to change lives on our campuses in our state and around the world.

UW employees bring their boundless energy creative problem-solving skills and dedication to building stronger minds and a healthier return they enjoy outstanding benefits opportunities for professional growth and the chance to work in an environment known for its diversity intellectual excitement artistic pursuits and natural beauty.

Our Commitment

The University of Washington is committed to fostering an inclusive respectful and welcoming community for all. As an equal opportunity employer the University considers applicants for employment without regard to race color creed religion national origin citizenship sex pregnancy age marital status sexual orientation gender identity or expression genetic information disability or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process contact the Disability Services Office at or .

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.