Location
Scheduled Hours
40

Position Summary
Provides administrative and operational leadership for strategic clinical research infrastructure initiatives within the Department of Psychiatry, including the development of a department-wide research program to systematically collect standardized clinical data, patient-reported information, biospecimens, and biomarker-related data from patients seen in the department. This initiative requires the employee to partner with departmental leadership, investigators, clinical operations, informatics/EPIC teams, HRPO, OVCR, the Research Contracts Office, and other institutional stakeholders to develop protocols, workflows, governance processes, reporting structures, and quality controls that support compliant and sustainable implementation. Supports regulatory coordination, reporting and analysis, education/training, and QA/QI activities related to the department's clinical research infrastructure.

Job Description

Primary Duties & Responsibilities:

Leadership and Supervision of Clinical Research Staff

• 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.

Daily Operations

• 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.

Investigator/Trial Development and Financial Managment

• 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.

Enhance Clinical Research Recruitment

• 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.

Training, Education, and Quality Improvement

• 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.

Management

• 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.

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

Preferred Qualifications:

• Clinical Research and Management experience.

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 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

Work Experience:
No additional work experience unless stated elsewhere in the job posting.

Skills:
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

Grade
G15

Salary Range
$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.

Questions

For frequently asked questions about the application process, please refer to our External Applicant FAQ.

Accommodation

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