Associate Director of Clinical Research (Hybrid Opportunity)

The Division of Pulmonary, Allergy & Critical Care Medicine is seeking an Associate Director of Clinical Research to provide leadership and oversight of complex large or multiple small clinical research projects. Supervise multiple clinical research staff, leads, managers. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight. Mentor Clinical Research Managers.

The Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is comprised of a team of outstanding clinicians, scientists, and scholars dedicated to improving the lives of patients with serious lung disease. Our goal is to provide outstanding clinical and research training to the next generation of leaders in Pulmonary and Critical Care Medicine. We are committed to strong clinical investigations including the evaluation of new pharmacologic agents, which offer potentially promising therapeutic benefits, as well as outcome studies which characterize clinical parameters to effect positive changes in patient care.

This is a hybrid opportunity.

Responsibilities

Core Duties

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• Select, develop, and evaluate personnel to ensure efficient operations, including hiring, performance management, and related duties. Oversee staffing and overall resourcing for program(s) under purview. Mentor Clinical Research Managers.

• Audit operations to ensure effective implementation of internal processes and quality program. Provide leadership in identifying and implementing corrective actions/processes. Lead inspections or audits.

• Oversee development of effective participant recruitment and retention activities. Oversee development of regulatory documents, including consent forms, for studies.

• Make strategic decisions regarding new and existing clinical research projects that may impact resourcing, quality, safety and/or compliance of program(s) under purview. Lead or chair committees or task forces to address and resolve significant issues.

• Develop and/or implement research goals for a clinical trial(s)/ therapeutic program in collaboration with multiple faculty members and internal/external stakeholders.

• Oversee regulatory management of programs and troubleshoot complex regulatory issues. Mentor and train managers and staff on how to resolve compliance issues and regulatory challenges across programs/organizations.

• Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct. Lead process and quality improvement initiatives to ensure efficiency in implementation of new protocols.

• Manage and track research program financial status with regular reports to research leaders. Oversee development of appropriate study budgets that meet the needs of the research program.

• Engage in high-level outreach and networking opportunities in a program leadership capacity, representing the research program to a variety of internal and external audiences.

• Analyze trends in recruitment across the portfolio, develop and monitor use of standardized reporting of key metrics. Develop ideas and implement improved processes and tools to ensure program success and compliance.

• Contribute to analysis of data and preparation of manuscripts and scientific presentations.

Minimum Education

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Bachelor's degree in related field

Minimum Experience

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Five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.

Knowledge, Skills and Abilities

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• Excellent interpersonal skills.

• Excellent diplomacy skills

• Proficiency in Microsoft Office and database applications, and EHRs (i.e., REDCap Cloud, EPIC).

• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.

• Knowledge of medical terminology.

• Minimum of three years of demonstrated managerial experience.

• Demonstrated disease knowledge / study design experience of studies under purview.

Certificates and Licenses Required

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Qualifications

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Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver's License.

• Ability to drive day or night.

• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.