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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data captureelectronic Case Report Forms (eCRFs)programming of validation checkscustom functionsspecifications for edit checksimpact analysisrisk assessmenttroubleshooting system errorsdocumentation of programsform design

Soft Skills

effective communicationcustomer serviceteam collaborationguidance and trainingproblem-solvingattention to detailanalytical skillsadaptabilityinterpersonal skillscommitment to quality

Certifications

Bachelor degree in ScienceBachelor degree in EngineeringBachelor degree in Public HealthMaster's degree in ScienceMedidata Rave Study Builder TrainingForte EDC Study Builder Training