About The Position

Under moderate supervision, the Clinical Research Coordinator I (CRC-I) is expected to perform all core Clinical Research Coordinator (CRC) responsibilities for human subjects’ (clinical) research. Study management includes but is not limited to assisting in assessing feasibility of clinical research protocols, preparing materials needed for regulatory review and submission to the Institutional Review Board (IRB), identifying potential study participants, collecting research data/specimens, completing study records in an accurate and timely manner, participating in quality assurance audits, managing study materials and supplies, communicating across multiple teams, and archiving records in accordance with appropriate policies and procedures. The CRC-I may also be responsible for development of source documents and/or case report forms and coordination of research/project team meetings. The CRC-I is the second position in the Clinical Research Coordinator series.

Requirements

  • Minimum one (1) year of clinical research coordination experience.
  • Associate degree or equivalent additional experience can be accepted in lieu of education.
  • Basic knowledge of key Microsoft Office programs (Word, Excel, PowerPoint).
  • Able to communicate effectively both orally and in writing.
  • Demonstrate strong interpersonal skills.
  • Be detail oriented.
  • Able to work under pressure in a fast-paced environment while managing multiple competing priorities.
  • Working knowledge of human subjects’ regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for Good Clinical Practice (ICH-GCP).
  • RQI Responder- American Heart Association. If incumbent does not have certification at time of hire or promotion, certification is expected to be obtained within six (6) months of assuming position. With management approval, the time in which to obtain certification may be extended past six (6) months due to extenuating circumstances.

Nice To Haves

  • Clinical research experience in a hospital setting and/or pediatric clinical research experience.
  • Bachelor’s degree.
  • Ability to conduct informed consent.
  • Working knowledge of Cerner or equivalent electronic medical record system.
  • Knowledge of sample identification, processing and storage.
  • Phlebotomy certification.

Responsibilities

  • Assisting in assessing feasibility of clinical research protocols
  • Preparing materials needed for regulatory review and submission to the Institutional Review Board (IRB)
  • Identifying potential study participants
  • Collecting research data/specimens
  • Completing study records in an accurate and timely manner
  • Participating in quality assurance audits
  • Managing study materials and supplies
  • Communicating across multiple teams
  • Archiving records in accordance with appropriate policies and procedures
  • Development of source documents and/or case report forms
  • Coordination of research/project team meetings
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