Associate Director of Clinical Research (IIT & Program Strategy Focus) - Radiation Oncology

About this role

Location ST. LOUIS, MO 63108

 Scheduled Hours 40

Position Summary The Department of Radiation Oncology at Washington University School of Medicine is seeking a highly experienced, strategic, and systems-oriented Associate Director of Clinical Research Operations. Under the direct guidance of the Department Chair / Interim Clinical Trials Director and the Executive Director of Business Affairs, this individual will serve as the primary operational leader for our expansive clinical trials enterprise.

As our department enters a new phase of strategic growth, a primary mandate of this role will be the rapid expansion, standardization, and oversight of our Investigator-Initiated Trials (IIT) portfolio, which includes landmark multi-disciplinary grants (e.g. our ROBIN U54 center) and pioneering global protocols in SBRT and cardiac radioablation. We are seeking a collaborative leader who can navigate scientific complexity, translate clinical inputs into strategic program plans, and implement enterprise-level systems to elevate overall organizational performance. The successful candidate will bring a systems-oriented approach to process improvement, empowering our existing teams while promoting consistency, compliance, and high-quality execution across all phases of oncology research

Job Description

Primary Duties & Responsibilities:

IIT Program Expansion & Leadership • Lead the strategic growth of the department's Investigator-Initiated Trials (IIT) portfolio. • Support principal investigators through concept development and governance review, and oversee the operational execution of complex early-phase and multi-center oncology studies.

Operational Leadership & Mentorship • Direct the day-to-day operations of the Clinical Trials Office, including the direct supervision, mentorship, and performance evaluation of the Clinical Research Manager. • Oversee cross-functional teams, manage critical paths, and ensure staffing strategies align with program-level planning. • Design and implement career development pathways to improve research staff retention and engagement. • Partner collaboratively with existing departmental research leadership during the initial onboarding phase to ensure a seamless transfer of historical institutional knowledge and trial continuity.

Systems Integration & Process Optimization • Lead the implementation and optimization of enterprise research systems, including EDC and eRegulatory platforms. • Assess institutional system capabilities to determine feasibility and drive EHR-to-EDC integration initiatives to reduce manual data entry and improve data integrity.

Program Budget & Financial Forecasting • Oversee the clinical trials program budget and partner with department finance and research administration on financial forecasting. • Develop advanced project and financial tracking tools (e.g., Smartsheet dashboards) to enhance leadership visibility into timelines, workloads, budgets, and accrual performance.

Strategic Institutional Collaboration • Foster strong, collaborative relationships with key institutional partners across Washington University and BJC HealthCare (e.g., CTMS offices, Biorepositories, Research Administration, and hospital/laboratory groups) to streamline workflows and overcome institutional bottlenecks.

Regulatory Compliance & Quality Assurance • Overhaul and maintain program SOPs and guidance documents. • Ensure all trials maintain strict compliance with FDA, ICH/GCP, and OHRP regulations. • Manage site feasibility, qualification, and oversight for multi-center studies.

Working Conditions: Job Location/Working Conditions • Normal office environment

Physical Effort • Typically sitting at a desk or a table

Equipment • Office equipment

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education: Bachelor's degree Certifications /Professional Licenses : No specific certification/professional license is required for this position.

Work Experience: Clinical Research (8 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.

More About This Job Required Qualifications: • Bachelor’s degree in biological sciences, healthcare administration, public health, nursing, business, or a related field. • Eight years of progressive leadership experience in clinical research operations and program management, strictly within an academic medical center or complex oncology setting.

Preferred Qualifications: • Master’s degree (MHA, MPH, MBA, or MSN). • Five years of direct personnel management, including experience supervising mid-level managers. • Exceptional cross-functional leadership skills with the ability to manage complex, multi-site investigator consortia. • Extensive, proven expertise in managing, scaling, and operationalizing Investigator- • Initiated Trials (IIT) and early-phase oncology portfolios. • Demonstrated experience leading the rollout of enterprise research platforms (EDC/eReg) and developing advanced project tracking tools/dashboards. • Expert-level knowledge of FDA, ICH/GCP, and OHRP regulations. • Proven track record of building collaborative structures that support innovation and process improvement.

Preferred Qualifications

Education: Master's degree Certifications /Professional Licenses : Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA), Clinical Research Associate (CRA) - Association of Clinical Research Professionals (ACRP), Clinical Research Management (CRM) - Association of Clinical Research Professionals (ACRP), Clinical Resea

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