Senior Electronic Data Capture Analyst

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.

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.
• Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
• Performs other related duties as assigned or requested.
  

Basic education, experience and skills required for consideration:

• Must have Master's degree in Science, Engineering, or Public Health;
• Must have a minimum of 5 years' experience in healthcare / clinical research setting.
• Must have experience in form design and programming in an EDC, such as Medidata Rave, Oracle InForm and/or Forte Oncore / EDC is highly desired;
• Must have 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;
• Must express commitment to City of Hope's mission, personally identify with its vision and takes pride in shared success.
• Must anticipate needs, respond quickly, provide guidance and support, and monitor and follow up as required.
• Must have excellent written and oral communication.

Preferred education experience and skills:

• Experience in clinical research operations, protocol development, and/or as research coordinator;
• Medidata Rave Study Builder Training, Forte EDC Study Builder Training;
• 5+ years of experience in healthcare / clinical research setting.

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.