Clinical Research Coordinator 2

Company: Stanford Medicine
Location: Mountain View
Posted on: January 13, 2022

Job Description:

Pay Grade: H

FTE: 100%

Stanford University 'Maternal & Child Health Research Institute', on behalf of the Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition, is seeking a Senior Clinical Research Coordinator (CRC2) to conduct clinical research and work independently on complex projects/assignments in the area of Pediatric Inflammatory Bowel Disease (IBD) and Celiac Disease.

The selected candidate must have the ability to implement, organize and conduct all aspects of clinical studies combined with knowledge of good clinical practice (GCP) and health care economics including insurance billing, research-related financial and budgetary processes (tracking study costs and sponsor payments). S/he will support patients participating in research studies and medical faculty in all aspects of clinical and translational research studies including regulatory compliance, study implementation, protocol development, data management, teaching and training of clinical staff, and maintaining research databases that are used to promote high quality care and improve performance in the clinical care of patients. Previous clinical research experience is required. Previous clinical trial experience at Stanford and/or LPCH is highly desirable.

The selected candidate will work within the Pediatric IBD and Celiac Disease Program, which is supported by a transformative philanthropic gift. Clinical research within the program will include patient biobanking and data collection concurrent with clinical care, local investigator-initiative study, and multicenter investigator-initiated studies and industry-sponsored clinical trials.

The Pediatric GI Division has approximately 30 pediatric gastroenterologists with nationally recognized expertise through their research, teaching, and clinical programs which attracts leading candidates to their fellowship program. We have a mission of healing children with digestive disease through innovation. Our Pediatric GI Specialty provide comprehensive GI care to children throughout our region. We lead global destination programs that deliver highly specialized care and train the next generation of pediatric gastroenterologists, and inspire hope through innovation. Our high quality, collaborative care is driven by cutting-edge research and active partnerships between doctors, nurses, and staff throughout the Stanford Children's Health network, scientists at Stanford University, and patient families. Together, we are changing the lives of children today and shaping care for tomorrow.

The Department of Pediatrics is a dynamic, stimulating place to work and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.

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:
  
  • A bachelor's degree in the biological sciences, medicine or public health is highly desired.
  • Excellent oral and written communication skills
  • Experience with managing clinical data in a research setting
  • Proficiency in using computers, software, and web-based applications in a previous administrative setting
  • Experience training , mentoring, and/or supervising others on topics related to clinical research conduct and management
  • Proficiency in Spanish (verbal and written) desired.
    
    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. Additional trainings and competencies obtained through continuing education, training coursework, webinars, etc. in any area of performing clinical research is strongly 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 disease and infections.
        • Position may at times require being on-call and/or require working during weekend, extended or unusual work hours based on research requirements and business needs.
        • Position will be required to support studies that are conducted at off-site clinics (within a 20-mile radius of the main campus). Incumbent will need to provide own transportation with the ability to get to/from these off-site clinics
          Position will require air flight travels to certain destinations (domestic and international, as needed) in order to participate in research-related events such as Investigator Meetings
          
          Additional Information
          
          • Schedule: Full-time
          • Job Code: 4923
          • Employee Status: Regular
          • Pay Grade: H
          • Department URL: http://pediatrics.stanford.edu/
          • Requisition ID: 91667 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, Mountain View , Clinical Research Coordinator 2, Healthcare , Mountain View, California