Clinical Research Coordinator 2

Company: Stanford Medicine
Location: San Bruno
Posted on: June 18, 2022

Job Description:

Stanford University is part of a NIH-sponsored clinical trial being conducted through the NIH HEAL Initiative's Back Pain Consortium (BACPAC) Research Program. The study's aim is to inform a precision medicine approach to the treatment of chronic low-back pain (cLBP). This is a multi-site, sequential, multiple assignment randomized trial (SMART) to evaluate four evidence-based interventions for cLBP.

We are seeking a Clinical Research Coordinator 2 (CRC2) to help oversee the project and work independently on progressively more complex projects/assignments. The CRC2 will work closely with the principal investigator, train and oversee research assistants, and independently manage significant and key aspects of the study. This position will allow for the opportunity to collaborate with top researchers and pain specialists at Stanford. For those interested in ultimately pursuing professional careers, we have a strong track record for successfully transitioning staff to medical school, MD/PhD programs, graduate schools (ie MS or PhD) and other professional programs. We have also helped grow and develop those who wish to make a career in research administration. We provide opportunities to get involved in side projects to lead to develop manuscripts and/or posters for national presentation.

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:
  
  • Experience running multiple/large clinical trials.
  • Experience with randomized controlled clinical trials.
  • Experience with NIH funded research.
  • Strong experience with all aspects of data management: collection, management, and integrity. Some experience with data analysis.
  • Knowledge of actigraphy.
  • Knowledge of running research participants in studies that involve MRI scanning.
    
    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
            • Requisition ID: 94383 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-policyby Jobble

Keywords: Stanford Medicine, San Bruno , Clinical Research Coordinator 2, Healthcare , San Bruno, California