Clinical Research Coordinator 2

Company: Stanford Medicine
Location: San Bruno
Posted on: June 24, 2022

Job Description:

The Division of Sleep Medicine within the Department of Psychiatry & Behavioral Sciences at Stanford University's School of Medicine has garnered global recognition for sleep-related advancements in patient care, research and education, and is a recognized leader in the management of sleep disorders. The Division has a storied history that had its origin in 1972 as the world's first sleep clinic and laboratory; since then, Stanford Sleep Medicine is recognized as one of the world's largest and best-known sleep centers.

The Division of Sleep Medicine is seeking an experienced Clinical Research Coordinator 2 (CRC 2) to work alongside Dr. Emmanuel Mignot to manage complex clinical trials related to sleep medicine. The CRC 2 will independently manage significant and key aspects of multiple research studies and will oversee the evening recruitment.

Due to the nature of the research being conducted, interested applicants should be available to work evenings.

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
  
  DESIRED QUALIFICATIONS:
  
  Bachelor's degree in medicine and/or scientific field (e.g. biological sciences, etc.)
  
  --- Knowledge and experience with GCP
  
  --- Excellent oral and written communication skills
  --- Experience with managing clinical data entry
  --- Proficiency in using computers, software, and web-based applications in a previous administrative setting
  --- Experience training others on topics related to clinical research conduct and management
  --- Additional trainings and competencies obtained through continuing education, training coursework, webinars, etc., in any area of performing clinical research is strongly preferred.
  
  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 disease 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 bases 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
              • Requisition ID: 93269 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 , Clinical Research Coordinator 2, Healthcare , San Bruno, California