About The Position

This position assists with screening, consents, enrollment, and maintaining research subjects while ensuring compliance with research protocols. The Clinical Research Coordinator acts as a liaison between monitors, investigators, and study personnel for all data management related to patients in clinical trials. Responsibilities include abstracting accurate and timely data from medical records and maintaining protocol regulatory documents in compliance with standard operating procedures (SOPs). The role also focuses on providing a safe environment for patients, families, and clinical staff.

Requirements

  • Associate degree in Clinical, Healthcare or Scientific related field of study.
  • Two (2) years of Allied health, medical or research related experience.
  • Equivalent combination of work/academic experience may be considered (i.e., Bachelor's degree in clinical, healthcare or scientific related field of study).
  • Computer skills (word processing, spreadsheets, database, data entry).

Nice To Haves

  • SoCRA or ACRP certification
  • Oncology medical research experience
  • Medical office experience preferable in oncology
  • Medical terminology knowledge

Responsibilities

  • Compiles medical records of research subjects during on-study, treatment, and follow-up periods and reports required elements to the research sponsor.
  • Ensures protocol compliance and accurate data submissions during the treatment and post-treatment phases of a research trial.
  • Ensures research tasks are completed correctly by referencing the most current research protocol and accessing sponsor resources.
  • Maintains accurate data on research patients in the research department database.
  • Ensures medical records accurately reflect research billing guides.
  • Develops and maintains a systematic approach to ensure all research data is reported within the time frame specified by the protocol.
  • Performs query resolution in a timely manner.
  • Prepares research records and participates in monitor visits or audit inspections.
  • Participates in protocol-specific training (initiation visits) conducted by the sponsor.
  • Facilitates communication between the study sponsor, research nurses, and investigators.
  • Performs tasks associated with the enrollment and active treatment period of research subjects.
  • Collects and ships research specimens, gathers and submits radiological scans, and performs clinical procedures such as EKGs as required by the research sponsor.
  • Assists in ensuring investigational drugs are maintained and distributed according to the protocol and FDA guidelines.
  • Assists in screening, consenting, and re-consenting research subjects.
  • Provides a safe environment for patients, families, and clinical staff.
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