Senior Quality Assurance Monitor FSM/CC

Department: MED-Cancer Center
Salary/Grade: EXS/7

Target hiring range for this position will be between be $65,000-$78,500 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

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.
• 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.

Miscellaneous

• Performs other duties as assigned.

Minimum Qualifications:

• Bachelor's degree in an allied medical profession or other health sciences field or the equivalent combination of education and experience from which comparable skills can be acquired.
• Excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations. 3-5 year's prior experience coordinating or monitoring therapeutic clinical trials.
• Experience with electronic data capture (EDC).
• 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.
• Attention to detail and a methodical approach to work.
• Fluent written and verbal English language skills.

Preferred Qualifications:

• 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.
• Experience in the review of case report forms (CRFs) and source documentation to ensure adherence to the protocol, and consistency and validity of the data. Prior experience in a cancer research setting preferred.

Preferred Competencies: (Skills, knowledge, and abilities)

• Knowledge of data management and case report form development preferred.

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.