Clinical Research Coordinator

Company: Stanford Medicine
Location: Santa Clara
Posted on: January 10, 2022

Job Description:

The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is an interdisciplinary center with focus on understanding the mechanisms of the immune system, the dysfunctions of which result in allergic reactions. A leader in allergy research, our Center works collaboratively with other researchers around the world to create a data-sharing cluster of information from our interlinked satellite centers to run novel and innovative clinical trials in allergy research. Our Center includes Stanford specialists in diverse fields including immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, and genetics. Through laboratory and computational research, clinical trials, community outreach, and other efforts, the team works toward finding rationally-based therapies to provide the safest and best treatments for allergies and asthma. Research at the Center may have implications for a wide array of immune dysfunctions including asthma, eczema, food allergies, eosinophilic disorders, drug allergies, gastroenterological diseases, and more.

The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is seeking a Clinical Research Coordinator (Clinical Research Coordinator Associate) to perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the principal investigator and/or study coordinator/supervisor.

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.
• 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.
  *- The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.
  
  DESIRED QUALIFICATIONS:
  
  • Bachelor's degree and one year of work experience in a related field or an equivalent combination of related education and
  • relevant experience.
  • Proficiency in use of electronic data capture systems is preferred.
  • Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
    
    EDUCATION & EXPERIENCE (REQUIRED):
    
    • Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
      
      KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
      
      • Strong interpersonal skills.
      • Proficiency with Microsoft Office.
      • 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 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/ .
              
              Why Stanford is for you
              
              Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
              
              
              • Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
              • A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
              • A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
              • Discovery and fun. Stroll through historic sculptures, trails, and museums.
              • Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.
                *- Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
                
                Additional Information
                
                • Schedule: Full-time
                • Job Code: 4924
                • Employee Status: Regular
                • Pay Grade: F
                • Requisition ID: 91648 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, Santa Clara , Clinical Research Coordinator, Accounting, Auditing , Santa Clara, California