Job TitleClinical Research Systems Analyst Job Code Title Job Requisition Number 096259 Department 0910- RES Clinical Trials Office Location Medical Center Job Type Officer Full-Time Regular Bargaining Unit If temporary, indicate duration Hours Per Week 35 Job Family General Administration Salary Grade Officer 105 Salary Range Advertised Summary Job Description Reporting directly to the Executive Director (the "Director") of the Clinical Trials Office at Columbia University Irving Medical Center ("CUIMC"), the Clinical Research Systems Analyst (the "Analyst"), assists the Director in overseeing the configuration, data management and quality assurance for all research systems in the CTO. The successful candidate will work with senior departmental management to maintain data integrity, data standardization, and data accuracy of the research systems operated by the CTO. Also, the candidate will provide data reporting and analytics, requiring the review of data requests. Duties and responsibilities of the Analyst will include, but not limited to, the following: 1. Collaborates with the CTO Management Team, CUIMC faculty and administration, NYPH administration, EPIC, EPIC Together, Sponsored Projects Administration (SPA), CUIMC IT, CUIT, and the Human Research Protections Office (HRPO) in meeting the institutional needs regarding clinical trial compliance, quality assurance, training and process-improvement goals. 2. Responsible for workflow design and re-design, planning, testing, evaluation, implementation, adoption, customization of applications including IBM CTMS and Epic. 3. Provide on-going training at various levels to ensure the users are optimizing system functionality and are appropriately trained; this also includes development of training program and materials for the software applications. 4. Provide daily support and be a resource to staff in resolving user issues related to system use and/or functionality. 5. Collect data and create reports on usage of the research systems to identify the utilization of best practices, errors, or misuse. 6. Recommend solutions to enhance and maximize workflow for the practices. 7. Coordinate and host regular customer conference calls for governance or trouble shooting with executive management level. 8. Work closely with vendors to resolve issues. 9. Data extraction and manipulation using various tool. 10. Liaise with external vendors for all systems Coordinating and facilitating the processes for entering data into the Clinical Trials Management Software (CTMS) and the Electronic Data Capture (EDC) systems for all users. 11. Review and update clinical trials entered into the CTMS and EDC systems to include new study information and/or study amendments. 12. Liaises with CUMC department/division investigators and coordinators to maintain on-going support for entering clinical trials information into the CTMS and EPIC systems. 13. Ensure standard operating procedures are consistently maintained on the CTMS and EPIC systems and provide report to CTO management. 14. Provide training in the CTMS and EPIC systems to applicable personnel. 15. Provide support in implementing new software and workflow processes. 16. Maintains strict data integrity and quality control standards for the CTO databases. 17. Demonstrate high computer literacy skills and ability to maintain data integrity and perform quality assurance on an ongoing basis for multiple applications. 18. Primary responsibility for timelines, completeness, accuracy and security of data. 19. Extracts data for publication, statistical reports, and other data collection requirements on tight deadlines. 20. Reviews any issues that deviate from standard procedures with CTO management. 21. Builds general knowledge base of policies, procedures, and documentation associated with clinical trials, using appropriate source material and doing research as needed. Minimum Qualifications for Grade Applicant MUST meet these minimum qualifications to be considered an applicant Requires a bachelor's degree or equivalent in education or experience, and four years of related experience. Additional Position-Specific Minimum Qualifications Applicant MUST meet these minimum qualifications to be considered an applicant Special Instructions Preferred Qualifications 1. Bachelor's degree in Computer Science, Mathematics, Engineering or related field, or equivalent training/experience/years of related service. 2. Demonstrate ability to lead a project toward goals in a timely manner. 3. Demonstrate ability to understand clinical research and associated processes and applications. 4. Excellent verbal, written and editorial communication skills with an attention to detail
Clinical Research Systems Analyst
Saturday, January 12, 2019
Computer & IT
Job TitleClinical Research Systems Analyst Job Code Title Job Requisition Number 096259 Department 0910- RES Clinical Trials Office Location Medical Center Job Type Officer Full-Time Regular Bargaining Unit If temporary, indicate duration Hours Per Week 35 Job Family General Administration Salary Grade Officer 105 Salary Range Advertised Summary Job Description Reporting directly to the Executive Director (the "Director") of the Clinical Trials Office at Columbia University Irving Medical Center ("CUIMC"), the Clinical Research Systems Analyst (the "Analyst"), assists the Director in overseeing the configuration, data management and quality assurance for all research systems in the CTO. The successful candidate will work with senior departmental management to maintain data integrity, data standardization, and data accuracy of the research systems operated by the CTO. Also, the candidate will provide data reporting and analytics, requiring the review of data requests. Duties and responsibilities of the Analyst will include, but not limited to, the following: 1. Collaborates with the CTO Management Team, CUIMC faculty and administration, NYPH administration, EPIC, EPIC Together, Sponsored Projects Administration (SPA), CUIMC IT, CUIT, and the Human Research Protections Office (HRPO) in meeting the institutional needs regarding clinical trial compliance, quality assurance, training and process-improvement goals. 2. Responsible for workflow design and re-design, planning, testing, evaluation, implementation, adoption, customization of applications including IBM CTMS and Epic. 3. Provide on-going training at various levels to ensure the users are optimizing system functionality and are appropriately trained; this also includes development of training program and materials for the software applications. 4. Provide daily support and be a resource to staff in resolving user issues related to system use and/or functionality. 5. Collect data and create reports on usage of the research systems to identify the utilization of best practices, errors, or misuse. 6. Recommend solutions to enhance and maximize workflow for the practices. 7. Coordinate and host regular customer conference calls for governance or trouble shooting with executive management level. 8. Work closely with vendors to resolve issues. 9. Data extraction and manipulation using various tool. 10. Liaise with external vendors for all systems Coordinating and facilitating the processes for entering data into the Clinical Trials Management Software (CTMS) and the Electronic Data Capture (EDC) systems for all users. 11. Review and update clinical trials entered into the CTMS and EDC systems to include new study information and/or study amendments. 12. Liaises with CUMC department/division investigators and coordinators to maintain on-going support for entering clinical trials information into the CTMS and EPIC systems. 13. Ensure standard operating procedures are consistently maintained on the CTMS and EPIC systems and provide report to CTO management. 14. Provide training in the CTMS and EPIC systems to applicable personnel. 15. Provide support in implementing new software and workflow processes. 16. Maintains strict data integrity and quality control standards for the CTO databases. 17. Demonstrate high computer literacy skills and ability to maintain data integrity and perform quality assurance on an ongoing basis for multiple applications. 18. Primary responsibility for timelines, completeness, accuracy and security of data. 19. Extracts data for publication, statistical reports, and other data collection requirements on tight deadlines. 20. Reviews any issues that deviate from standard procedures with CTO management. 21. Builds general knowledge base of policies, procedures, and documentation associated with clinical trials, using appropriate source material and doing research as needed. Minimum Qualifications for Grade Applicant MUST meet these minimum qualifications to be considered an applicant Requires a bachelor's degree or equivalent in education or experience, and four years of related experience. Additional Position-Specific Minimum Qualifications Applicant MUST meet these minimum qualifications to be considered an applicant Special Instructions Preferred Qualifications 1. Bachelor's degree in Computer Science, Mathematics, Engineering or related field, or equivalent training/experience/years of related service. 2. Demonstrate ability to lead a project toward goals in a timely manner. 3. Demonstrate ability to understand clinical research and associated processes and applications. 4. Excellent verbal, written and editorial communication skills with an attention to detail