at Northwestern University in Evanston, Illinois, United States
Job Description
Job Opening Id: 50450
Department: MED-Cancer Center
Salary/Grade: EXS/7
Job Summary:
The Quality Assurance Monitor (QAM) is responsible for ongoing monitoring of clinical trial data for local, investigator-initiated clinical trials, concentrating on data accuracy and completeness, protocol adherence, and toxicity and response review. The QAM work focuses on Phase I, I/II, and II protocols, and (s)he interacts directly with each study PI as issues arise. While the QAM reports directly to the CRO’s QA/QC Manager, this person is also responsible to and reports all findings to the Lurie Cancer Center’s Data Monitoring Committee. Ongoing review includes study participant registration, data submission and protocol compliance, toxicity review, adverse event monitoring, and response review. The QAM works directly with the study PI and statistician to provide data in support of publications.
Please note: This person must wear a pager during work hours. Work hours are Monday-Friday and must encompass the hours of 8:30-4:00
Specific Responsibilities:
- 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.
