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Senior Clinical Research Coordinator and Regulatory Lead

Company: Stanford Medicine
Location: Santa Clara
Posted on: May 9, 2022

Job Description:

Stanford University is seeking a Clinical Research Coordinator 2 (CRC) to join Dr. Franc and the Radiology Department within School of Medicine.

Dr. Franc predominantly publishes and lectures on applications and innovations of PET-CT. He has proficiency in all aspects of PET radiopharmaceutical development, spanning the design of molecules, synthesis of radioligands, and use in animal and human imaging. He also has expertise in quantitative image analysis, development of novel post-processing image reconstruction methods, and the application of artificial intelligence in human diagnostics. Dr. Franc has implemented new radiopharmaceuticals in pre-clinical and clinical research PET imaging as well as for clinical PET with applications in cancer, infectious disease (HIV), and autoimmune disease (RA).

In the CRC role, you will conduct clinical research and work independently on progressively more complex projects/assignments. Including but not limited to managing significant and key aspects of a large study or all aspects of one or more small research studies.

This position is based on Stanford University's School of Medicine campus with a hybrid work schedule (partially onsite and offsite), subject to operational need. Interested candidates should include a resume and cover letter.

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.

    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
                • Department URL: http://radiology.stanford.edu/
                • Requisition ID: 92689 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 , Senior Clinical Research Coordinator and Regulatory Lead, Healthcare , Santa Clara, California

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