Senior Electronic Data Capture Analyst - Remote

City of Hope

4d•Remote

About The Position

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.

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.

Nice To Haves

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

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.