Associate Director of Clinical Research (IIT & Program Strategy Focus) - Radiation Oncology
Washington University in St. Louis
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Benefits offered by this job
Job summary
Washington University in St. Louis is seeking an Associate Director of Clinical Research Operations to lead IIT expansion, standardization, and enterprise systems across the department.
This high-impact role partners with department leadership to advance multi-site oncology trials, oversee budgets, implement EDC/eReg platforms, and improve data integrity, staffing, and compliance in a complex academic medical center.
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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- Foster strong, collaborative relationships with key institutional partners across Washington University and BJC HealthCare to streamline workflows and overcome institutional bottlenecks.
- Overhaul and maintain program SOPs and guidance documents.
- Ensure all trials maintain strict compliance with FDA, ICH/GCP, and OHRP regulations.
Education
Job description
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.
ST. LOUIS, MO 63108
40
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Bachelor's degree
No specific certification/professional license is required for this position.
Clinical Research (8 Years)
Not Applicable
A driver's license is not required for this position.
More About This Job
- 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.
- 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.
Master's degree
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 Research Professional (CRP) - Association of Clinical Research Professionals (ACRP), Registered Nurse - Illinois Department of Financial and Professional Regulation, Registered Nurse - Missouri Division of Professional Registration
No additional work experience unless stated elsewhere in the job posting.
Building High Performance Team, Clinical Research, Clinical Research Operations, Clinical Research Organizations (CRO) Management, Clinical Trials, Compliance Management, Compliance Requirements, Data Reporting, Diplomacy, External Stakeholders, Financial Acumen, Grants Management, Grant Writing, Internal Stakeholders, Interpersonal Communication, Leadership, Project Planning, Protocol Development, Regulatory Submissions, Standard Operating Procedure (SOP) Development, Strategic Planning
G15
$84,200.00 - $148,500.00 / Annually
The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.
For frequently asked questions about the application process, please refer to our External Applicant FAQ.
If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.
All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
- Up to 22 days of vacation, 10 recognized holidays, and sick time.
- Competitive health insurance packages with priority appointments and lower copays/coinsurance.
- Take advantage of our free Metro transit U-Pass for eligible employees.
- WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
- Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
- We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.
- WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.
For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, citizenship (where prohibited by federal law), age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.
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