at Northwestern University in Chicago, Illinois, United States
Job Description
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Job ID50451
LocationChicago, Illinois
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Department: MED-Cancer Center
Salary/Grade: EXS/5
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.
Manage daily operations of a biomedical &/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors and other external project stakeholders.Monitors study performance, analyzes and review results and supervises development & implementation of new protocols.May co-author scientific papers for presentation & publication & coordinates writing, submission and administration of grants.Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state and federal laws, regulations, guidance, policy and procedure developed by the NU Institutional Review Board IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH)
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
Ascertains pretreatment & eligibility requirements
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 all adverse events submitted to ensure appropriate reporting requirements have been met.Follows all serious adverse events through resolution.
Reviews data and identifies quality issues
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 in tables below.
Enterprise Applications:
EIACUC
eIRB
Kronos
Infrastructure (extends across applications):
Microsoft Office (Word, Excel, Powerpoint, Access, Outlook)
Certification/Licensure:
CCRC, CCRP, CCRA
Compliance:
21 CFR Part 11
HIPAA
IACUC
IRB
Analytical:
Critical thinking
Data warehouse design/develop
Database design/ data structure
Decision making
Problem solving
Troubleshooting
Process improvement, optimization
Project:
Agile environment
Collaboration and teamwork
Evaluate resources
Facilitate collaboration
Functional documentation
Organizational skills
Planning
Minimum Competencies: (Skills, knowledge, and abilities.)
Strong regulatory background as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines.
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:
2 years prior experience coordinating or monitoring therapeutic clinical trials.
Experience with data completion or familiarity... 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.
