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Clinical Research Coordinator Associate

Company: Stanford Medicine
Location: Union City
Posted on: January 10, 2022

Job Description:

Stanford Department of Obstetrics & Gynecology's mission is to improve women's health through innovative and compassionate care, education, advocacy and discovery. Our faculty is committed to the highest level of basic and clinical research in Obstetric and Gynecologic science. In particular, we are focused on innovative translational medicine; bringing scientific results from the bench to the bedside.

To support our growing department, we are seeking a Clinical Research Coordinator Associate (CRCA) to join the Maternal-Fetal Medicine & Obstetrics research team to perform duties related to the coordination of clinical studies varying from industry sponsored research to multi-center randomized controlled trials. The Division of Maternal-Fetal Medicine and Obstetrics is engaged in a spectrum of maternal-fetal medicine and obstetric research from early pregnancy and placentation studies to prenatal diagnosis andfetal therapy research, to clinical trials and cohort studies. CRCA joining the team is expected to coordinate moderately complex aspects of one or more clinical studies under close direction of the research operations manager and/or the principal investigator. Experience working with diverse populations is preferred.

For more details about the department: https://obgyn.stanford.edu.

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-- some protocols may require the CRC to collect and process the research samples.
  • 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.

    * - Other duties may also be assigned.

    DESIRED QUALIFICATIONS:
    • Spanish speaking.
    • Phlebotomy certificate.

      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 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.

            Additional Information
            • Schedule: Full-time
            • Job Code: 4924
            • Employee Status: Regular
            • Pay Grade: F
            • Department URL: http://obgyn.stanford.edu
            • Requisition ID: 91612 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, Union City , Clinical Research Coordinator Associate, Other , Union City, California

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