Quality Monitor Coordinator FSM/CC

Job Summary :

Utilizes multiple quantitative and qualitative datasets from a variety of sources and interprets results using various techniques, ranging from simple data aggregation via statistical analysis to complex data mining.

Assists in the design, development and implementation of business solutions partnering with clients to identify analytical requirements.

Compiles reports, charts, and tables based on established statistical methods.

Manage daily operations of a biomedical & / or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors and other external project stakeholders.

Monitors study performance, analyzes and review results and supervises development & implementation of new protocols. May co-author scientific papers for presentation & publication & coordinates writing, submission and administration of grants.

Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state and federal laws, regulations, guidance, policy and procedure developed by the NU Institutional Review Board IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH)

Specific Responsibilities :

Strategic Planning

• Partners with clients to define requirements based on business objectives.
• Leads execution & control of research data bases for trial endpoints
• Ensures completion of study activities per protocol including recruitment
• Develops new and / or revised research methodologies
• Ascertains pretreatment & eligibility requirements

Administration

• Develop standardized templates, policies, and procedures for internal and external reporting.
• Comply with current local, state and federal regulatory guidelines, requirements, laws and research protocols completion in a timely manner.
• Designs and prepares documentation for qualitative and quantitative data analysis.
• Oversees and manages collection, maintenance, analysis and evaluation of data to be used in grant submissions, presentations and publications
• Ensures information is entered correctly into databases.
• Assists PI in reviewing, analyzing, interpreting, summarizing, formatting, editing, preparing tables, charts, graphs, progress and final reports, etc.
• Coordinates between sponsoring, collaborating and affiliate agencies.

Development

• Completes a variety of statistical analyses using appropriate data and software
• Merges data from multiple sources in preparation for analysis.
• Interprets results of analyses for use in reports and presentations
• 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.

Performance

• Completes data cleaning and organizes data files for analysis.
• Reviews all adverse events submitted to ensure appropriate reporting requirements have been met. Follows all serious adverse events through resolution.
• Reviews data and identifies quality issues

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications :

Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree;

OR appropriate combination of education and experience.

Please see information in tables below.

Enterprise Applications :

• EIACUC
• eIRB
• Kronos
• Infrastructure (extends across applications) :
• Microsoft Office (Word, Excel, Powerpoint, Access, Outlook)

Certification / Licensure :

CCRC, CCRP, CCRA

Compliance :

• 21 CFR Part 11
• HIPAA
• IACUC

Analytical :

• Critical thinking
• Data warehouse design / develop
• Database design / data structure
• Decision making
• Problem solving
• Troubleshooting
• Process improvement, optimization

Project :

• Agile environment
• Collaboration and teamwork
• Evaluate resources
• Facilitate collaboration
• Functional documentation
• Organizational skills
• Planning

Minimum Competencies : (Skills, knowledge, and abilities.)

• Strong regulatory background as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines.
• 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 :

• 2 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.

Target hiring range for this position will be between $49,850-$69,000 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.

Benefits :

At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at 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 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 to learn more .

Northwestern strongly recommends COVID-19 vaccinations and boosters for people who can obtain them as a critical tool for minimizing severe illness.

More information can be found on the webpage.

The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations.

We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.

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.