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Sr. ICU Clinical Research Coordinator

Company: Stanford Medicine
Location: San Leandro
Posted on: January 13, 2022

Job Description:

The Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is comprised of a team of outstanding clinicians, scientists, and scholars dedicated to improving the lives of patients with serious lung disease. Our goal is to provide outstanding clinical and research training to the next generation of leaders in Pulmonary and Critical Care Medicine. We are committed to strong clinical investigations including the evaluation of new pharmacologic agents, which offer potentially promising therapeutic benefits, as well as outcome studies which characterize clinical parameters to effect positive changes in patient care.

PACCM is seeking a Sr. ICU Clinical Research Coordinator (Clinical Research Coordinator 2) to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

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:
    • Knowledge of data analysis in R or Python is a plus and would enable greater input into data analysis but not required.
    • Advanced medical knowledge is a major plus, and interest in learning with PI MD team in depth about inpatient ICU medicine is required to enable optimal enrollment of patients across numerous studies
    • Skilled in communication with patients, families, and health care team
    • Knowledge of International Conference on Harmonization (ICH) guidelines essential
    • Advanced certification such as a CCRA or CCRC, certification from a Clinical Research Training Program or equivalent or willingness to pursue this certification in first 6 months on the job.
    • Leadership experience is a plus, as this position will have several direct reports within Stanford, and lead multi-institutional meetings with other sites.

      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.

              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.

                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: 89611 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 Leandro , Sr. ICU Clinical Research Coordinator, Healthcare , San Leandro, California

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