Senior Electronic Data Capture Analyst
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Job Description
Senior EDC Analyst supporting a portfolio of clinical trials at City of Hope. Focused on electronic data capture and collaboration with research teams.
Responsibilities:
- Support a vast portfolio of City of Hope therapeutic investigator-initiated studies that require data capture in a robust database.
- Work directly with study teams (Principal Investigators, Statisticians, Study Coordinators, etc) to understand specific workflows and requirements and build electronic Case Report Forms (eCRFs).
- Design, develop, validate, and maintain applications used to capture eCRF data within Forte EDC.
- Provide programming of validation checks and custom functions on eCRFs to improve data quality.
- Develop specifications for standard edit checks, data listings and reports as needed.
- Work closely with research software developers / programmers to ensure that validations within Forte EDC meet study team needs.
- Create documentation related to requirements, user testing, findings, etc.
- Provide end user support; communicate with participating sites on data related tasks.
- Maintain familiarity with Bug / Issue Tracking tools to keep apprised of issues related to EDC software.
- Maintain familiarity with EDC-related industry Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines.
- Provide guidance and training to other analysts and assist other department staff members as necessary.
- Maintain effective communication with study teams related to protocol status and amendments that affect eCRFs.
- Perform impact analysis and risk assessment on all proposed application changes.
- Troubleshoot system errors.
- Maintain documentation of all programs and applications.
- Support research, evaluation and development of departmental initiatives and new technologies/innovations to improve processes.
Requirements:
- Bachelor degree in Science, Engineering, or Public Health.
- A minimum of 5 years’ experience in healthcare / clinical research setting.
- Experience in form design and programming in an EDC, such as Medidata Rave, Oracle InForm and/or Forte Oncore / EDC, highly desired.
- Experience in clinical research operations, protocol development, and/or research coordinator a plus.
- Master's degree in Science preferred.
- Medidata Rave Study Builder Training, Forte EDC Study Builder Training preferred.
- 5+ years of experience in healthcare / clinical research setting.
- Ability to analyze complex clinical trial protocols and refine language into an external system.
- Must have the ability to work closely and effectively with a diverse group of administrators.
- Must have a passion for excellent customer service and commitment to exceptional quality.
- Excellent written and oral communication.
Benefits:
- Comprehensive Benefits
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