Clinical Research Lead

Company: Stanford Medicine
Location: San Mateo
Posted on: January 10, 2022

Job Description:

The Department of Medicine, Division of Gastroenterology and Hepatology is seeking a Clinical Research Lead (Clinical Research Coordinator 2) to oversee and partner with the Principal Investigator in several NIH and Industry-sponsored Clinical studies focused on diagnosis, biomarker discovery and validation, and treatment of various pancreatic disorders.

The Division of Gastroenterology and Hepatology has a long tradition of major contributions in basic research, a new commitment to clinical and outcomes research, a track record of training fellows for academic careers, and a longitudinal commitment to providing care for patients with complex gastrointestinal and liver diseases.

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.
  *- 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:
  
  • Strong Organizational Skills
    
    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 in 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 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: 4923
                • Employee Status: Regular
                • Pay Grade: H
                • Requisition ID: 89830 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 Mateo , Clinical Research Lead, Healthcare , San Mateo, California