Columbia University Clinical Research Systems Analyst in New York, New York

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


  1. Demonstrate high computer literacy skills and ability to maintain data integrity and perform quality assurance on an ongoing basis for multiple applications.

  2. Primary responsibility for timelines, completeness, accuracy and security of data.

  3. Extracts data for publication, statistical reports, and other data collection requirements on tight deadlines.

  4. Reviews any issues that deviate from standard procedures with CTO management.

  5. 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.

  1. Demonstrate ability to lead a project toward goals in a timely manner.

  2. Demonstrate ability to understand clinical research and associated processes and applications.

  3. Excellent verbal, written and editorial communication skills with an attention to detail required.

  4. Excellent interpersonal and presentation skills.

Essential Functions

Additional Essential Functions (Limit to 3950 characters.)

Special Indications

This position works with:

HIPAA Compliance training required No Response

Participation in Medical Surveillance required No Response

What type of posting? Is this a waiver request? Standard Posting

Requisition Open Date 01-10-2019

Requisition Close Date Open Until Filled

Quick Link

EEO Statement Columbia University is an Equal Opportunity/Affirmative Action employer --Race/Gender/Disability/Veteran.

Local Hiring Columbia University is committed to the hiring of qualified local residents.

This organization is a federal contractor subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA). The final rules now require contractors and subcontractors to invite applicants to self-identify as protected veterans or individuals with disabilities.

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