Job Summary
Department-Specific Responsibilities
- Determines and verifies patient eligibility per study requirements and ensures consents are obtained for the clinical trial.
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 Principal Investigator (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.
Qualifications
Required
- Bachelor's degree in science or a health-related field and 2 years of clinical research experience. OR
- Associate's degree in science or a health-related field and 3 years of clinical research experience.
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