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Clinical Systems Designer (PST/EST/CST Timezone)

2 hours, 35 minutes ago
Brazil
Full-time
Junior
Business Analyst
Operations
Git
Apply Now
Fast Affordable Solutions

Fast Affordable Solutions

Fast Affordable Solutions provides virtual staffing solutions that connect businesses, startups, and executives with highly skilled, English-speaking professionals, streamlining the hiring process to be fast, affordable, and efficient while also offeri...

Professional Services
Founded 2021
View All Jobs 6

Description

  • Translate study protocols into compliant, user-friendly e-source templates in CRIO.
  • Build study visit schedules, assessments, procedures, and workflows in CRIO and, where applicable, Clinical Conductor and RealTime CTMS.
  • Develop and maintain electronic regulatory binders in CRIO and other CTMS platforms as needed.
  • Ensure study builds meet sponsor/CRO requirements and site operational needs.
  • Ensure compliance with FDA, ICH-GCP, and 21 CFR Part 11 regulations.
  • Standardize filing procedures and perform QC on document uploads.
  • Map study procedures to financial tracking and align billing with study requirements.
  • Link contracted budgets to procedures and site invoicing accurately.
  • Develop SOPs and best practices for e-source and e-regulatory build processes.
  • Provide training, support, troubleshooting, and updates based on coordinator and investigator feedback.

Requirements

  • Bachelor’s degree in Life Sciences, Clinical Research, or related field, or equivalent experience.
  • At least 1 year of direct experience building e-source and e-regulatory documents in CRIO (required).
  • Experience with e-source and e-regulatory builds in Clinical Conductor and/or RealTime CTMS (strongly preferred).
  • Strong understanding of clinical trial protocols, regulatory compliance, and site operations.
  • Ability to map procedures to budgets and financials in CTMS platforms.
  • Strong attention to detail, documentation, and version control.
  • Excellent communication and collaboration skills.
  • Experience across multiple CTMS/EDC platforms with e-source build responsibilities (preferred).
  • Process optimization and SOP development experience (preferred).
  • Knowledge of site-level finance, billing, and reconciliation workflows (preferred).

Interested in this position?

Apply directly on the company website

Apply Now

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