Clinical Research Specialist

1 week ago

Phoenix, Arizona, United States Phoenix Children's Hospital Full time
Job Overview

Position Title: Clinical Research Coordinator

Department: RSRCH-GRNT | Genetics Research Studies

Location: Phoenix

Position Summary

This role entails overseeing a range of research initiatives from the initial planning stages to the final closure. The Clinical Research Coordinator will independently manage the collection of specimens, extraction and input of patient information, and ensure the maintenance of comprehensive and precise subject data along with regulatory documentation. Additionally, this position offers administrative and regulatory support, which includes recruiting, interviewing, and scheduling study participants, as well as processing necessary regulatory documents in compliance with federal, state, and institutional guidelines.

Key Responsibilities
  1. Regulatory Compliance: Ensure that all assigned studies adhere to the standards set by the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional protocols. This includes:
    • Reviewing regulatory requirements to implement suitable methods and procedures for research activities.
    • Completing and submitting necessary documents to the appropriate Institutional Review Board (IRB) and committees.
    • Maintaining up-to-date and accurate documentation in regulatory binders as mandated by regulations and sponsors.
    • Collaborating with the principal investigator to explain study objectives and requirements to participants.
  2. Sponsor Interaction: Fulfill all obligations set by study sponsors, which includes:
    • Providing regulatory documents to sponsors promptly.
    • Completing case report forms, data entry, and maintaining source documentation for all participants.
    • Tracking and reporting adverse events according to sponsor and institutional guidelines.
    • Coordinating research monitor visits and addressing all data inquiries.
  3. Study Initiation: Manage the process of launching new studies by:
    • Gathering necessary background information on proposed research projects and presenting findings to the principal investigator.
    • Completing feasibility assessments.
    • Circulating confidentiality agreements and trial contracts to relevant parties.
    • Creating study budgets and collaborating with management to assess financial viability and resource requirements.
    • Assisting in the development of workflow procedures tailored to specific protocols.
  4. Participant Recruitment: Engage in the recruitment and selection of study participants, ensuring informed consent is obtained and that all eligibility criteria are satisfied.
  5. Medical Coordination: Schedule and coordinate various medical procedures and tests, including laboratory tests, imaging studies, and evaluations as dictated by study protocols.
  6. Participant Education: In collaboration with the principal investigator and other team members, provide study-specific education to participants and their families regarding procedures, documentation, and treatment protocols.
  7. Financial Oversight: Review financial reports related to study participant billing, expenditures, and revenue. Maintain inventory levels of supplies and equipment, initiating requisitions for replacements as necessary.
  8. Professional Development: Participate in ongoing professional development programs to stay informed about current methodologies and practices relevant to the patient population and research area.
  9. Additional Duties: Perform miscellaneous job-related tasks as required.
Phoenix Children's Mission, Vision, & Values

Mission: To advance hope, healing, and the best healthcare for children and their families.

Vision: Phoenix Children's aims to be the leading pediatric health system in the Southwest, recognized nationally for exceptional care, innovative research, and advanced medical education.

Values:

  • Children and families are at the center of all we do.
  • We deliver exceptional care, every day and in every way.
  • Collaboration with colleagues, partners, and communities amplifies our impact.
  • We set the standards of pediatric healthcare today and innovate for the future.
  • We are accountable for making high-quality care accessible and affordable.

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