Cancer Clinical Research Manager 2 (Hybrid)

The Stanford Cancer Institute’s Clinical Trials Office (SCI-CTO) is the centralized organization for cancer clinical research operations at Stanford Medicine. The SCI-CTO, with over 200 staff, provides high-quality and efficient services supporting the development, activation, and completion of scientifically impactful cancer clinical trials serving the SCI’s catchment area. The SCI earned its most recent comprehensive cancer center designation by the NCI in 2022 and is a prominent, growing, and complex Institute within Stanford Medicine. Cancer clinical research is integrated throughout Stanford Medicine, which comprises the Stanford School of Medicine and our adult and pediatric health systems – Stanford Health Care and Stanford Children’s Health. The SCI actively works to build synergies and collaborations across Stanford Medicine.

About the role

Reporting to the Director of Clinical Research, the Executive Clinical Research Manager (ECRM) will provide oversight, guidance, and support for the conduct of cancer clinical research to assigned Clinical Research Groups (CRG(s)). The ECRM will be conversant in the goals, mission, and priorities of the Institute and utilize this knowledge to conduct impactful clinical research with a focus on high quality and efficiency. This position collaborates closely with physician investigators and clinical research staff to drive the successful implementation of cancer clinical trials.

Responsibilities

• 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.

Requirements

• Bachelor's degree in a related field.
• Five years of experience in clinical research, or an equivalent combination of education and relevant experience.
• Master’s degree preferred.
• Minimum of three years of demonstrated managerial experience.
• Excellent interpersonal and 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.
• Demonstrated disease knowledge/study design experience of studies under purview.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
• Oncology experience preferred.
• Experience in a hospital and/or clinic setting preferred.

Physical Requirements

• Frequently stand, walk, twist, bend, stoop, squat, and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone, and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

Working Conditions

• May be exposed to bloodborne pathogens.
• May be required to work non-standard, extended, or weekend hours in support of research or project work.

Work Standards

• Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures.

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.