Note: The job is a remote job and is open to candidates in USA. Washington University School of Medicine in St. Louis is seeking an Associate Director for Clinical Research in the Psychiatry department. The role involves providing leadership and operational oversight for clinical research initiatives, developing research programs, and ensuring compliance and quality in clinical research activities.
Responsibilities
- Provides day-to-day supervision of assigned program staff, including workload prioritization, professional development and training, performance feedback and coaching, and resolution of operational barriers
- Evaluates direct-report staff assigned to the program
- Develops role definitions, staffing plans, onboarding processes, training materials, workflows, and performance expectations for staff assigned to the program
- Leads development of protocols, consent workflows, data collection processes, biospecimen and biomarker workflows, reporting structures, and related operational standards
- Builds and maintains productive relationships with partners within WashU Medicine and with external collaborators
- Establishes governance, prioritization, and communication processes to support effective implementation and long-term sustainability of the program
- Meets regularly with key stakeholders, users, investigators, clinical leaders, and operational partners to monitor implementation progress, identify barriers, and evaluate program performance
- Assists investigators with logistical and operational planning related to development of new clinical research projects utilizing data maintained in the participant repository
- Develops streamlined processes, templates, and start-up pathways for studies that leverage departmental data, biospecimen, biomarker, or recruitment infrastructure
- Supports preparation of operational plans, timelines, metrics, and resource models for clinical research proposals and related funding applications
- In partnership with departmental leadership, develops and monitors budgets related to program staffing, operations, infrastructure, and sustainability
- Works to leverage the Epic Electronic Health Record system to support cohort identification, standardized data collection, recruitment workflows, reporting, and study feasibility assessment
- Develops mechanisms to promote clinical study recruitment best practices and improve access to research participation opportunities across the Department
- Supports implementation of workflows for patient-reported information, clinical data capture, biospecimen collection, biomarker tracking, and related quality metrics
- Partners with stakeholders to monitor data completeness, recruitment performance, workflow adoption, and operational barriers
- Identifies opportunities to improve integration of research workflows into clinical settings while minimizing burden on patients, clinicians, and research teams
- Develops and coordinates educational programs, training materials, guidance documents, and standard operating procedures for investigators, research staff, clinicians, and operational partners participating in the program
- In collaboration with OVCR, HRPO, and other institutional offices, develops and disseminates policies and procedures related to human subjects research, data collection, biospecimen collection, privacy, and regulatory compliance
- Establishes quality assurance and quality improvement processes to support protocol adherence, data integrity, workflow consistency, and regulatory compliance
- Supports risk-based self-monitoring and corrective action planning for applicable investigator-initiated studies and infrastructure-supported research activities
- Monitors program metrics and quality indicators to identify gaps, improve workflows, and support continuous improvement
- Provides strategic input on program goals, implementation priorities, staffing needs, operational risks, resource requirements, and sustainability planning
- Represents the Department’s clinical research infrastructure initiatives within the Department and at institutional meetings
- Provides administrative and operational leadership for the design, build, and implementation of shared clinical research infrastructure in the Department
Skills
- Bachelor's degree
- Clinical Research (8 Years)
- Clinical Research and Management experience
- 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
- 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
Benefits
- 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.
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