Senior Electronic Data Capture Analyst

For Pipelines only:Thanks you for your interest. Please note the purpose of this posting is to recruit for on-going and future positions.




About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.The Senior EDC Analyst will support a vast portfolio of City of Hope therapeutic investigator-initiated studies that require data capture in a robust database. This includes over 100 clinical trials that have been historically supported by Medidata Rave and will continue to be supported by Forte EDC beginning in 2019. The team behaves as EDC experts and maintains primary responsibility over form design, development, validation, and updates on a recurring basis until study closure.

Position Summary:

The Senior EDC Analyst will support a vast portfolio of City of Hope therapeutic investigator-initiated studies that require data capture in a robust database. This includes over 100 clinical trials that have been historically supported by Medidata Rave and will continue to be supported by Forte EDC beginning in 2019. The team behaves as EDC experts and maintains primary responsibility over form design, development, validation, and updates on a recurring basis until study closure.

Key Responsibilities include:

• 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.
  

Basic education, experience and skills required for consideration:

• Master's 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 (Electronic Data Collection), 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.

Preferred education experience and skills:

• Master's degree in Science.
• Preferred Courses/Training: 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.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer.All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.