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Senior Clinical Research Coordinator and AI Lead

Company: Stanford Medicine
Location: San Bruno
Posted on: January 15, 2022

Job Description:

Stanford University is seeking a Clinical Research Coordinator 2 (CRC2) and AI Lead to join the Department of Radiology within the School of Medicine. Stanford Radiology has been among the top ten NIH-funded radiology departments each year since 2005, including drug and devise studies from phase I to IV. The Department of Radiology takes on a unique position within the School of Medicine. It includes a wide area of modalities and disease groups and collaborates with numerous clinicians and researchers in other departments to develop improved scientific, diagnostic, and therapeutic applications. It also takes on a world-leading role with the initiative of the Stanford Center for Artificial Intelligence in Medicine and Imaging (AIMI Center). The AIMI Center's primary mission is to solve clinically important problems in medicine using AI. We are seeking a Lead CRC2 to help us enact our mission to reduce disease through comprehensive research, treatment, education, and outreach programs. The Lead CRC2 will be working with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of health care. Candidates need to demonstrate excellent CRC2 skills, outstanding communication, and organizational skills, and attention to detail to work independently on AI projects and clinical trials across a wide range of diseases. The CRC2 Lead will work in a dynamic atmosphere within and with a multifaceted team of fellow coordinators and physicians, scientists, technologists, nurses, and research fellows. Outstanding communication and organizational skills and attention to detail are required in a successful candidate. The coordinator will be responsible for ensuring compliance with federal, state, local, and sponsor regulations and work under the direction of their manager. Duties include:

  • Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
  • Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
  • Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
  • Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
  • 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.
  • Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
  • Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
  • Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
  • Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
  • Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. * - Other duties may also be assigned. EDUCATION & EXPERIENCE (REQUIRED):
    • Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
      • Strong interpersonal skills
      • Proficiency with 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. CERTIFICATIONS & LICENSES:
        • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License. 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, http://adminguide.stanford.edu . As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy Additional Information
                • Schedule: Full-time
                • Job Code: 4923
                • Employee Status: Regular
                • Pay Grade: H
                • Department URL: http://radiology.stanford.edu/
                • Requisition ID: 92385 As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy

Keywords: Stanford Medicine, San Bruno , Senior Clinical Research Coordinator and AI Lead, Healthcare , San Bruno, California

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