The Senior Data Assistant serves as a resource to staff regarding data entry, maintenance, and results. Coordinates incoming data for accuracy and integrity, assists with complex data preparation, analyzes data, and creates reports. Ensures associated administrative tasks such as documentation, editing of code books and manuals, etc. are completed. The Senior Data Assistant is responsible for the compilation of all data for clinical trials managed by the CTO. 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.
Identifies and assesses customer data needs.
Assists in identifying organizational area's data integration and related records solutions.
Collaborates on a variety of data management projects including variable definitions, storage, etc.
Obtain required training for all electronic data capture systems.
Obtains applicable protocol specific training.
Abstract all required patient data from medical record sources for entry into case report forms (paper and/or electronic).
Follow timelines stated in SOP (CO-SM-312) and individual sponsor contracts, for data entry and query resolution.
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.
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.
Ensures that all data is obtained and verified for subsequent analysis.
Provides updates and summaries regarding statistics.
Provides administrative support to organizational area.
Attend mandatory scheduled meetings
Increase knowledge of all disease specific oncology studies to ensure efficient data abstraction and resolution of queries.
Assesses protocol compliance and communicates directly with the study coordinator and PI when compliance issues are identified.
Assist with all internal audit request.
Gives input on CTO policies and procedures with regards to data entry/monitoring.
Writes queries and reports and creates necessary analysis.
Schedule and participate in all monitor visits for assigned studies.
Facilitate EMR access for monitors.
Resolve issues noted in follow up letter within 3 weeks.
Assists with any sponsor audit requests
Runs and distributes standard scheduled reports.
Maintains and updates report inventory.
Experience with the following:
Enterprise Applications: EIACUC, eIRB, Kronos.
Infrastructure: Microsoft Lync, Microsoft Office (Word, Excel, Powerpoint, Access, Outlook),
Certification/Licensure: Microsoft (MCSE, MCSD, MCSA).
Compliance: 21 CFR Part 11, FDA GLP, HIPAA, IACUC, IRB.
Analytical: critical thinking, decision making, problem solving, Troubleshooting.
Project: collaboration and teamwork, evaluate resources, organizational skills, planning, workflow development & documentation.
A high school diploma or equivalent is required.
4 years' data entry of 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.
Bachelor’s degree in the health sciences, social sciences, or advertising/marketing.
Experience in data management in a health field, exposure to cancer clinical trials.
Computer literate in basic software, internet use, and cancer-related databases.
At least 1 year of work experience in a customer service oriented position.
1-2 years’ experience in cancer research.
1-2 years’ experience in Clinical Trials.
Preferred Competencies: (Skills, knowledge, and abilities)
Prior administrative or public responsibility desirable
Experience in data management in a health field
Exposure to cancer clinical trials
Communication – Oral and Written
As per Northwestern University policy, this position requires a criminal background check. Successful applicants will need to submit to a criminal background check prior to employment.
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.