Cancer Clinical Research Manager - Breast Oncology

Stanford Cancer Institute – Clinical Trials Office – Clinical Research Manager – Breast Oncology (Hybrid Work Schedule) The Stanford Cancer Institute (SCI) was re-designated as a comprehensive cancer center by the NCI in early 2022, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Clinical Research Manager for Breast Oncology to help us enact our mission to reduce cancer mortality through comprehensive cancer research, treatment, education, and outreach programs. Given the SCI’s mission, breadth, and depth, we thrive in a fast-paced, team-oriented, and forward-thinking environment, it employs over 375 staff in a fast-paced environment, with tremendous opportunities for personal and professional growth. The Clinical Trials Office (CTO) is an integral component of the Stanford Cancer Institute. The vital work enables our adult and pediatric cancer centers to translate research from the laboratory into clinical settings. You will be working with a leading-edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena. Reporting to the Director of Clinical Research or an Associate Director of Clinical Research, the Clinical Research Manager (CRM) Breast Oncology will support cancer clinical research focused in oncology. The CRM will be conversant in the goals, mission, and priorities of the Institute and utilize this knowledge to conduct impactful clinical research focusing on high quality and efficiency. We are seeking candidates with excellent organizational skills, attention to detail, and a willingness to learn. Candidates must be eager to take on challenges with a high degree of professionalism, initiative, and flexibility. Responsibilities include working with the research team, clinical staff, and Stanford Health Care departments to support safe and compliant clinical research. Duties include: Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators. Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel. Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions. Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group. Lead or chair committees or task forces to address and resolve significant issues. Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences. Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance. Assist with analysis of data and preparation of manuscripts and scientific presentations. DESIRED QUALIFICATIONS: Clinical research certification. Previous experience in oncology, specifically breast. Experience with clinical trial finance management. EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Excellent interpersonal skills. Proficiency in Microsoft Office and database applications. 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 managerial experience. CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is 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. WORKING CONDITIONS: Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. WORK STANDARDS: Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: 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, including but not limited to the personnel policies and other policies found in the University's Administrative Guide.

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