Clinical Research Coordinator

Website IUCancerCenter IU Simon Comprehensive Cancer Center

Job Summary

Department-Specific Responsibilities

  • Assists with development of study recruitment materials for participant contact and/or re-contact, including preparation of regulatory applications.
  • Partners with advocates and those with expertise in community outreach and engagement to identify best practices for participant recruitment.
  • Communicates with pathology labs and biobanks to identify appropriate biospecimens.
  • Coordinates with current research staff to manage new data and biospecimens.
  • Participates in the development of abstracts, manuscripts and grant proposals.

General Responsibilities

  • Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
  • Participates in study budget negotiations and reconciles study budget accounts.
  • Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
  • Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
  • Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
  • Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
  • Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
  • Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
  • Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
  • Stays up to date with knowledge of regulatory affairs and/or issues.

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