Clinical Trials Data Assistant

Department: MED-Cancer Center

Salary/Grade: NEX/11

Target hiring range for this position will be between be range is as be $23.71-$28.00 per hour. 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:

Ensures submission and maintenance of accurate, timely, complete and reliable data and reports by implementing data management and quality assurance procedures. Provides feedback to customers and clients regarding systematic data errors or problems. Documents revisions in codebooks and manuals.

• Responsible for the compilation of all data for clinical trials managed by the CTO. Manages project data including extraction, entering, processing, accuracy, analysis and evaluation of data ensuring that results meet project information and deliverable objectives.
• Serves as a resource to new staff regarding quality data entry, maintenance, and departmental policies. Assists with data for all teams and occasional audits. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports.
• Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data

Specific Responsibilities:

Strategic Planning

• Participates in team and other departmental meetings to share experiences, learn about what other teams are doing and help solve problems.

Administration

• Manages data receipt, tracking and follows up on assigned project(s).
• Detects trends and reports on patterns of errors.
• Contacts customers to obtain missing data.
• Compiles and maintains codebooks, data files and memos needed for subsequent analysis of data.
• Learns and complies with appropriate compliance and regulation requirements regarding protected data.
• Obtains required training for all electronic data capture systems.
• Gives input on CTO policies and procedures with regards to data entry/monitoring.
• Assesses protocol compliance and communicates directly with the study coordinator and PI when compliance issues are identified.

Development

• Edits, codes and enters data per protocol.
• Runs reports and completes basic analysis.
• Determines data needed to be collected and the appropriate data resources for specific study/project needs.
• Abstract all required patient data from medical record sources for entry into cas report forms (paper and/or electronic).
• Main contact for monitors/CRO's for data query resolution.

Performance

• Reviews data input for accuracy, addressing on skip patterns, coding, and other information.
• Performs cleaning/formatting tasks of datasets.
• Follow timelines stated in SOP (CO-SM-312) and individual sponsor contracts, for data entry and query resolution.
• Assists with data reconciliation

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• A high school diploma or equivalent is required.

• 2 years data entry or similar experience is required.

• Please see information highlighted below.

• Enterprise Applications

• eIRB

• Kronos

• Infrastructure

• Mac OS X Operating System

• Microsoft Exchange

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

• Ability to understand complex pathology data and cancer treatment regimens and their toxicity.

• Ability to establish and maintain effective working relationships with patients, physicians, nurses, technicians and coworkers.

• Excellent verbal and written communication

• Medical terminology

Preferred Qualifications:

• Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelors or higher degree; OR appropriate combination of education and experience.

• Experience in data management in a health field, exposure to cancer clinical trials.

• Computer literate in basic software, internet use, and cancer-related databases.

Preferred Competencies: (Skills, knowledge, and abilities)

• Experience with oncology clinical trials

• Experience with databases such as SAS/Access

Benefits:

At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, 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.