Clinical Research Supervisor

Company: Stanford Medicine
Location: Dublin
Posted on: June 26, 2022

Job Description:

The Divisions of Pediatric Critical Care Medicine is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. The Clinical Research Coordinator 2 will independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

This is an onsite role requiring you to be on campus in Palo Alto, CA.

We are a growing team including long-tenured faculty, staff, and leadership. The Division activities reach all parts of the mission: patient care, education, and research. The Clinical Research Coordinator 2 will have a great deal of exposure to all these areas and will be communicating with a broad range of individuals at the Executive level, internally and externally. Within the Divisions and Center, there is a strong operations team of about 15 people. We are a supportive group that prioritizes well-being, with many team events and opportunities for professional development and personal growth. We value balancing home and work life. We foster an environment that leads to fulfilling and rewarding careers at Stanford University for all staff. Please check out our website and social media channels below, and come see about working for an organization that directly impacts the lives of children.

https://med.stanford.edu/pedcriticalcare.html
https://twitter.com/stanfordpccm

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing-- some protocols may require the CRC to collect and process the research samples.
• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/ case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.
  
  * - Other duties may also be assigned
  
  DESIRED QUALIFICATIONS:
  
  • Spanish speaking
    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.
        
        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.
            
            Additional Information
            
            • Schedule: Full-time
            • Job Code: 4923
            • Employee Status: Regular
            • Pay Grade: H
            • Department URL: http://pediatrics.stanford.edu/
            • Requisition ID: 94774 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, Dublin , Clinical Research Supervisor, Accounting, Auditing , Dublin, California