Data Coordinator

Overview

The eSource Document Specialist / Data Quality Control Specialist is responsible for the creation, maintenance, and quality control of clinical research source documentation within the CRIO eSource platform.

This role ensures that all source documents adhere to Good Clinical Practice (GCP) and regulatory standards, as well as protocol-specific requirements. Additionally, the role oversees data quality management, ensuring clinical data accuracy and completeness across various phases of clinical trials.

• Create and maintain source documentation within set timelines according to protocol-required elements.
• Revise source documentation as necessary to reflect amendments or study-specific needs.
• Manage and maintain eSource platform software (CRIO), ensuring consistent use and updates.
• Collaborate with study management teams to incorporate feedback and ensure documents are tailored to site needs.
• Modify existing source documentation based on protocol amendments, sponsor, or site- required edits.
• Ensure adherence to Good Clinical Practice (GCP) throughout documentation processes.

• Bachelor’s degree in a related field (e.g., Clinical Research, Health Sciences) or equivalent experience strongly preferred.
• Minimum of 3 years of experience in clinical research, data management, or related roles.
• Knowledge of eSource platforms, particularly CRIO, and experience creating and maintaining clinical research documentation.
• Familiarity with clinical data management, including extraction, documentation, and review of clinical research forms (eCRFs/CRFs).
• Strong understanding of GCP, GDP, and regulatory guidelines in clinical research.
• Excellent communication and collaboration skills with the ability to work effectively across teams.
• High attention to detail and strong organizational skills.
• Proficiency with software and tools used in clinical research documentation and data management.