Note: The job is a remote job and is open to candidates in USA. City of Hope is a transformative organization dedicated to changing lives in the fight against cancer and other life-threatening illnesses. As a Senior Electronic Data Capture Analyst, you will support a portfolio of therapeutic studies by managing electronic Case Report Forms and ensuring data quality through various responsibilities including application development and user support.

Responsibilities

• Work directly with study teams (Principal Investigators, Statisticians, Study Coordinators, etc) to understand specific workflows and requirements and build electronic Case Report Forms (eCRFs) in alignment with a given research protocol requiring EDC support
• 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 specific to federal and local regulations
• 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. Report to regular conferences, training, and/or continuing education sessions to realize further department efficiencies and success
• Performs other related duties as assigned or requested

Skills

• 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
• Medidata Rave Study Builder Training, Forte EDC Study Builder Training
• 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
• Expresses commitment to City of Hope's mission, personally identifies with its vision and takes pride in shared success
• Anticipates needs, responds quickly, provides guidance and support, monitors and follows up as required
• Excellent written and oral communication

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