The responsibilities of the Quality Assurance Monitor will include:
- Protocol initiation – Reviews new protocols, specifically sections relating to registration procedures, records to be kept, eligibility criteria, and adverse event reporting. Collaborates in eCRF development for each study. Conducts and/or participates in study initiation visits prior to protocol activation, for both Northwestern and other participating sites. Works with Affiliate Site Coordinator and other members of QA team to activate affiliates.
- Protocol registration - Verifies eligibility of and registers/randomizes participants to studies monitored by the DMC.
- Data review - Reviews case report forms submitted for accuracy, protocol compliance and completeness. If errors exist, generates queries and submits them to the coordinator/data manager associated with the protocol.
- Toxicity review - Reviews all adverse events submitted to ensure appropriate reporting requirements have been met. Follows all serious adverse events through resolution. Manages safety report review for all trials for which Northwestern is considered the Sponsor of record.
- Phase I reporting – Summarizes and presents toxicity data on phase I studies for cohort analysis prior to dose escalation.
- General reporting – Reports data to the DMC as described by the Data and Safety Monitoring Plan and DMC requirements. Includes presentation of toxicity data, response data, Study Activity Reports, audit reports, FDA reports, and accrual status and compliance issues. Communicates findings to the PI during the conduct of the study and provides a summary of study data to the PI and statistician for the purposes of publication.
- Audit - Participates in the conduct of internal audits per Audit Committee guidelines. Generates audit reports to be presented to the Audit Committee and DMC. Performs other duties as assigned
Job ID: 233349
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