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Clinical Research Coordinator Associate

Company: Stanford Medicine
Location: San Leandro
Posted on: November 14, 2021

Job Description:

This position will be based on the Stanford campus and is a hybrid (working on-site and working from home) subject to operational need.

The Division of General Surgery at the Stanford School of Medicine is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies. The CRCA will coordinate moderately complex aspects of one or more clinical studies working under close direction of the principal investigator and/or Study Manager/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.
  • Interact with the principal investigator and/or Research Team 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.
    * - Other duties may also be assigned.

    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.

        DESIRED QUALIFICATIONS:
        • 3 years of experience in clinical research preferred.
        • Strong writing/editing skills.
        • Data savvy and comfortable with a moderate level of data extraction, management and analysis of results.
        • Fluent in both writing and/or speaking Spanish is a plus, but not required.
        • Knowledge of how to interpret sponsor agreements strongly preferred.
        • Strong background in clinical trials research, including protocol design; recruitment and screening of potential participants; identification and communication of adverse health effects
        • Must have the ability to directly coordinate clinical trials within a clinical research setting; demonstrated ability to work effectively within a moderately autonomous environment, in addition to having a complete commitment to achieving goals
        • Must be flexible, dependable & able to handle multiple priorities with conflicting deadlines.
        • Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.

          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:
              • Occasional evening and weekend hours.

                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 .

                  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.

                  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.

                  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
                  • Department URL: http://surgery.stanford.edu/
                  • Requisition ID: 91267 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 , Clinical Research Coordinator Associate, Accounting, Auditing , San Leandro, California

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