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.

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