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Clinical Trials Data Assistant
4 months ago
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
- Note: Not all aspects of the job are covered in this job description
**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.
**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 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)**
- Experience with oncology clinical trials
- Experience with databases such as SAS/Access
Target hiring range for this position will be between $23.71 - $27.84 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.
**_ Benefits:_**:
**_ 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._
**_ Professional Growth & Development:_**:
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 COVID-19 and Campus Updates 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._
