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.
  • Obtains applicable protocol specific training.
  • Responsible for the long term follow-up with patients who are no longer receiving active treatment which may involve direct contact with patients, their families and/or referring physicians.
  • Responds to sponsor/CRO data concerns and escalates issues to management as appropriate.
  • Provide Clinical data management support to Clinical Operations team and/or study project,
  • Participate in conference calls and/or meetings with vendors.
  • Attend mandatory scheduled meetings
  • Increase knowledge of all disease specific oncology studies to ensure efficient data abstraction and resolution of queries.
  • Assists in mentoring/training entry level data assistants.
  • Gives input on CTO policies and procedures with regards to data entry/monitoring.
  • Assists with development of case report forms for internal studies.

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 case report forms (paper and/or electronic).
  • Seek out data by contacting other hospitals and physician offices to obtain medical records as needed.
  • Main contact for monitors/CRO’s for data query resolution.
  • Collaborate with DB vendors on consistent basis to address clinical team requests, respond to sponsor queries, and resolve technical issues.
  • Ensure clinical data within EDC is in quality to lock/unlock as appropriate for statistical review, interim review, and or final database locks.
  • Perform close-out duties specified by sponsors for closing studies in EDC’s.
  • Schedule and participate in all monitor visits for assigned studies.
  • Facilitate EMR access for monitors.
  • Assists with any sponsor and/or internal audit requests.

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.
  • Manages data reconciliation.
  • Resolve issues noted in follow up letter within 3 weeks.
  • Assesses protocol compliance and communicates directly with the study coordinator and PI when compliance issues are identified.

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 in tables below.

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 co-workers.
• 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 bachelor's 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)

• 2 years' experience in cancer
• Experience with databases such as SAS/Access
• Experience working on Phase 1-IV clinical trials

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 requires all staff and faculty to be vaccinated against COVID-19, subject to limited exceptions. For more information, please visit our COVID-19 and Campus Updates website.

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.