Department Clinical Research Manager

Company: Stanford University
Location: Stanford
Posted on: September 20, 2023

Job Description:

The Department of Anesthesiology, Perioperative and Pain Medicine, at Stanford University's School of Medicine, is a world-leading department that offers comprehensive training, perioperative patient care, pain management, and critical care medicine. The department also engages in cutting edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education. The Department of Anesthesiology is seeking a Clinical Research Department Manager to provide leadership and oversight over the department's many large and multiple small clinical research projects. Supervise multiple departmental clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight. This position involves collaboration with top researchers and clinicians at Stanford to help advance cutting-edge and transformative research. We have a strong track record for successfully transitioning staff to professional programs and have also helped grow and develop those who wish to make a career in research administration. One of the roles of this position will be to help mentor junior staff and advance their career development. There will also be opportunities to interface with clinical research leadership across the School of Medicine. At Stanford University School of Medicine, our work touches the lives of those today and tomorrow. Through education, research, and health care, the School of Medicine improves health through leadership, diversity, collaborative discoveries, and innovation in health care. Whether working in departments with faculty, or in units that support the school, our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health.Stanford is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends, and benefits that increase financial stability and promote healthy, fulfilling lives. An award- winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers. Stanford's School of Medicine, and the Department of Anesthesia are committed to diversity, equity, and inclusion for its faculty, staff, residents, and postdocs, and fellows. We aim to recruit, support, retain, and promote diversity in our department.For more information on our department, please see our website: Duties include:

• Strategic Management and Coordination of Clinical Research Projects: assist in start-up of clinical research projects, track project progress, assist in logistical aspects and interface with university resources.
• 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.
• Assist in overseeing 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.
• 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.* - Other duties may also be assigned DESIRED QUALIFICATIONS:Master's or PhD degree preferredDemonstrated experience in management and supervision.Expertise managing single-site, large, federally or nationally-funded research clinical trials.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.KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
  • Excellent interpersonal skills.
  • Proficiency in Microsoft Office and database applications (e.g. REDCap).
  • 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.* - 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:
      • 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, .The expected pay range for this position is $108,000 to $136,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

Keywords: Stanford University, San Francisco , Department Clinical Research Manager, Executive , Stanford, California