Coord II: Clin Research, CR

Shriners Children's•Philadelphia, PA

About The Position

Coordinates and supports clinical research studies in a pediatric hospital setting, ensuring compliance with study protocols, regulatory requirements, and ethical guidelines. The role supports patient recruitment, data collection, and accurate research documentation. It requires knowledge of the clinical research process and regulatory requirements, along with coordination of study activities from protocol consideration through data reporting and dissemination. The coordinator works collaboratively with investigators, research leadership, sponsors, regulatory agencies, and site staff, and helps safeguard research participants. The role also provides consultation and mentorship on research processes, Good Clinical Practices, and applicable regulations.

Requirements

  • At least 3 years of clinical research experience, such as experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance.
  • If the candidate does not have a bachelor's degree, at least 5 years of specific job-related experience in clinical research administration.

Nice To Haves

  • Bachelor's degree in clinical research, science, or another healthcare-related field.
  • Master's degree in clinical research, science, or another healthcare-related field.
  • Experience coordinating intergroup or multi-site clinical studies.
  • CCRP or CCRC certification.

Responsibilities

  • Maintain current knowledge of clinical research regulatory requirements and working knowledge of the clinical research process, from protocol development through implementation.
  • Track project details, including study, investigator, and Institutional Review Board (IRB) information, patient recruitment activity, and financial management.
  • Work with investigators, research leadership, study sponsors, and regulatory agencies to conduct clinical research and report results.
  • Coordinate data collection, statistical analysis, and dissemination of results throughout a clinical study.
  • Evaluate protocols under consideration for feasibility, including data collection, entry, storage, and reporting processes.
  • Safeguard participants involved in research studies supported and approved by Shriners Children's.
  • Facilitate local-site research programs and projects through timely communication and teamwork.
  • Provide consultation and mentorship to site staff, residents, students, and volunteers on research processes, Good Clinical Practices, and clinical research regulations.
  • Coordinate research professionally and promptly with other departments.
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