Research - Laboratory/Non-Laboratory, Staff/Administrative
Department: MED-Cancer Center Salary/Grade: EXS/7
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 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 Quality Assurance Monitor works directly with the study PI and statistician to provide data in support of publications.
Protocol initiation – Reviews new protocols, specifically sections relating to registration procedures, records to be kept, eligibility criteria, and adverse event reporting. Responsible for eCRF development for each study. Conducts and/or participates in study initiation visits prior to protocol activation.
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.
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 - Organizes and 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.
Bachelor’s degree in an allied medical profession or other health sciences field or
Strong regulatory background as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines.
3-5 years prior experience coordinating or monitoring therapeutic clinical trials.
Experience with data completion or familiarity with data form completion guidelines.
Experience in staff education and training activities.
Minimum Competencies: (Skills, knowledge, and abilities.)
Computer literate in Microsoft Office, Internet, and database use.
Ability to establish and maintain effective working relationships with physicians, affiliate centers and coworkers.
Preferred Qualifications: (Education and experience)
Nursing degree, Master’s or other graduate level degree or the equivalent combination of education, training and experience from which comparable skills can be acquired.
3-5 years’ experience in clinical trial development.
Prior experience in a cancer research setting preferred.
Preferred Competencies: (Skills, knowledge, and abilities)
Knowledge of data management and case report form development preferred.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 36238
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.