at Northwestern University in Chicago, Illinois, United States
Job Description
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Job ID50161
LocationChicago, Illinois
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Department: MED-Cancer Center
Salary/Grade: EXS/6
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.
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
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 data and identifies quality issues
Assists in monitoring and auditing of data for clinical research trials
Creates timeliness reports and data analytics by disease teams
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 highlighted in tables below.
Enterprise Applications:
EIACUC
eIRB
Kronos
Infrastructure (extends across applications)
Microsoft Office (Word, Excel, Powerpoint, Access, Outlook)
Compliance
21 CFR Part 11
HIPAA
IACUC
IRB
Analytical:
critical thinking
data mining
data warehouse design/develop
database design/ data structure
decision making
judgment
problem solving
Troubleshooting
Project:
agile environment
collaboration and teamwork
evaluate resources
facilitate collaboration
functional documentation
organizational skills
planning
Other:
CCRC, CCRP, CCRA
Process improvement, optimization
Minimum Competencies: (Skills, knowledge, and abilities.)
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:
Strong regulatory background as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines.
2 years prior experience coordinating or monitoring therapeutic clinical trials.
2 years prior experience in clinical trial development
Experience with data completion or familiarity with data form completion guidelines.
Experience in staff education and training activities.
Prior experience in a cancer research setting preferred
Preferred Competencies: (Skills, knowledge, and abilities)
Knowledge of data management and case report form development preferred
Experience collaborating with multiple sites in clinical research
Understanding of the clinical trial start-up process
Familiarity with reviewing Serious Adverse Events (SAEs), CDAs and other clinical research specific documents.
Target hiring range for this position will be between $55,128-$77,525 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... For full info follow application link.
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.