Clinical Systems Specialist- e-source (CRIO)

Clinical Systems Specialist – e-source (CRIO) 

Position Summary 

The Clinical Systems Specialist (CRIO) is responsible for developing source documents, predominantly eSource within the CRIO system or paper source, as required by the study, for a network of clinical research sites. This role reviews study protocols, CRF guidance, sponsor-provided materials, and visit schedules to build compliant, visit-specific source templates that ensure all required study data are captured accurately and efficiently by site staff. 

The ideal candidate has previous experience with the CRIO platform, specifically, eSource, understands clinical research workflows, and can translate protocol requirements into clear, user-friendly source documentation. 

Key Responsibilities 

Review clinical study protocols, schedules of assessments, CRF guidance, and sponsor-provided materials to identify required data elements for each visit. 

Develop source documents for each study/site that capture all required protocol and EDC data fields. 

Build visit-specific source documents that align with protocol schedules and coordinator workflows. 

Ensure source documents include all regulatory-required elements and protocol-required documentation. 

Incorporate sponsor-specific requirements, screenshots, and data entry guidance into source builds when provided. 

Collaborate with study coordinators, site managers, and research leadership to confirm study workflow and documentation needs. 

Maintain consistency and standardization of source templates across the research network when appropriate. 

Update source documents when protocol amendments, site or sponsor updates occur. 

Ensure builds support efficient coordinator workflows and minimize duplicate data entry. 

Perform quality checks on builds before studying activation at sites. 

Provide complete source documentation in a timely manner for site review prior to greenlight. 

Qualifications 

Required 

Experience building electronic source documents in CRIO. 

Prior experience in clinical research operations (e.g., Clinical Research Coordinator, Data Manager, Regulatory Specialist, or similar). 

Strong understanding of clinical trial protocols and schedules of assessments. 

Familiarity with EDC systems and sponsor data collection requirements. 

Ability to interpret protocol requirements and translate them into structured source documentation. 

Strong attention to detail and organizational skills. 

Preferred 

Experience supporting multiple clinical research sites or networks. 

Experience working with sponsor-provided EDC guidance or annotated CRFs. 

Understanding of GCP (Good Clinical Practice) requirements related to source documentation. 

Prior experience with clinical trial start-up processes. 

Key Skills 

CRIO eSource build and configuration 

Protocol interpretation 

Clinical trial documentation standards 

Clinical research workflows 

Detail-oriented data structuring 

Cross-functional communication 

Position Type 

Full-time, remote position 

Reports To 

 SVP of Operations