Clinical Research Coordinator, Pediatric Hematology/Oncology

Job Summary

Department-Specific Responsibilities

• Determines and verifies patient eligibility per study requirements and ensures consents are obtained for the clinical trial.
• Collects and evaluates the study data and submits data reports to sponsors/principal investigators (PI).
• Ensures compliance with study schedules and data submission.
• Coordinates and ensures collection and processing of specimens as directed by the clinical trial.
• Coordinates site visits and monitoring visits with sponsors.
• Works with financial staff to determine study versus standard of care procedures for study billing compliance.
• Prepares and documents protocol deviations as required by sponsor and institutional review board (IRB). Prepares study documents, sponsor or regulatory agency audits, or monitoring visits.

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 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.