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Clinical Research Coordinator Associate, Pediatric Surgery (Hybrid Opportunity)

Company: Stanford University
Location: Stanford
Posted on: May 27, 2023

Job Description:

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

The Department of Surgery, Division of Pediatric Surgery at the Stanford University School of Medicine is seeking a Clinical Research Coordinator Associate (CRCA) to perform work related to the support of clinical studies. The CRCA will be primarily responsible for coordinating studies from start-up through close-out. This includes, but is not limited to, following study related workflows, conducting patient recruitment, following consent procedures, assisting with sample collection and processing, and adhering to IRB and Stanford's institutional regulations. The CRCA will work under close direction of the principal investigator and study managers/supervisors as well as work collaboratively with research study staff, clinicians, and the staff of Stanford clinics, hospitals, and departments. This role also requires assisting study staff with IRB requests, maintaining documentation and databases, extracting data, and preparing documentation for audits. As the division and studies within grow, other duties may be assigned.

Duties include:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up 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, acting as primary contact.
  • 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.

    • Bachelor's Degree in science or health related field is preferred.
    • Background in clinical research preferred.
    • Comfortable working with patients and guardians during the research consenting process.
    • Ability to assess patient's interest and willingness to consent.
    • Experience with electronic medical records and databases containing public health information (PHI).
    • Strong knowledge of medical terminology.
    • Excellent communication skills, energetic, motivated and work well both autonomously and as a team.
    • Possess a high level of initiative. Willingness to take on new projects and tasks, and want to grow within the division. 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.

      • 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 but not required. Stanford will provide training in HIPAA, CITI, and any other related clinical research training required to perform study duties and meet IRB and Stanford's institutional 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.

          Occasional evening and weekend hours.

          • 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, . The expected pay range for this position is $56,000 to $78,000 per annum.
            Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

            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.

            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.

Keywords: Stanford University, San Francisco , Clinical Research Coordinator Associate, Pediatric Surgery (Hybrid Opportunity), Healthcare , Stanford, California

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