ESource System Specialist

Posted Thursday, January 22, 2026 at 5:00 AM

The eSource System Specialist, in concert with the Director of Regulatory Affairs and Quality Assurance, is responsible for the configuration, implementation, maintenance, and optimization of the CRIO eSource platform across activities across a multi-site clinical research network. This role serves as a system subject-matter expert (SME), ensuring compliant, efficient, and scalable use of eSource to support nephrology and therapeutic clinical trials.

The Specialist partners closely with clinical operations, quality assurance, IT, and site staff to enable accurate source documentation, regulatory compliance, and operational efficiency utilizing eSource.

• Serves as the day-to-day system administrator and SME for the CRIO eSource platform.
• Configures study builds, visit schedules, templates, forms, and workflows aligned with Study Protocols, Study eCRF Guidelines, and PSL standard operational procedures (SOPs) for new studies and any amendments as required.
• Partners with clinical operations and site clinical research coordinator teams to ensure protocol-accurate source design.
• Provides regular updates on eSource progress for new studies and amendments to the PSL leadership with respect to timelines
• Provides ongoing study support, troubleshooting, and issue resolution of eSource throughout the trial lifecycle.
• Manages user access, role-based permissions, and audit trail integrity in accordance with 21 CFR Part 11 and PSL SOPs.
• Supports system validation of eSource enhancements prior to use, as applicable, and go-live readiness.
• Ensures system aligns with GCP, ALCOA+ principles, 21 CFR Part 11, and PSL SOPs.
• Develops and delivers eSource onboarding and refresher training for Investigators and clinical research study staff and tracks training completion and competency.
• Acts as first-line support for eSource end users, escalating issues to vendor as appropriate.
• Monitors eSource system performance and recommends improvements to optimize usability and efficiency.
• Identifies opportunities to improve workflows, reduce documentation burden, and enhance compliance through eSource optimization.
• Develops metrics and reports related to adoption, utilization, data quality, and cycle times of eSource.
• Develops and maintains PSL standard operational procedures (SOPs), work instructions, and job aids related to eSource.
• Ensures potential study risks are escalated to the attention of the Director when appropriate.
• Performs other duties and responsibilities as required, assigned, or requested

• Bachelors’ degree in Business or Health Science preferred or equivalent experience
• 3+ years of experience in clinical research operations, clinical research informatics, or eSource/EDC system support, with a strong understanding of clinical research protocols.
• Experience with other eSource or EDC platforms (e.g., Medidata Rave, Veeva, Epic Research).
• Requires excellent interpersonal and communication skills.
• Requires flexibility, excellent organizational/communication skills, and attention to detail.
• Must be able to multitask and able to handle a high volume of studies.
• Knowledge of and adherence to GCP, 21 CFR Part 11, and data integrity principles.

The Company is committed to the principles of equal employment. We are committed to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment which is free of harassment, discrimination, or retaliation because of age, race, color, national origin, ancestry, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed service member status, or any other status protected by federal, state, or local laws.

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