The Source Document Specialist is responsible for designing, building, and maintaining high-quality clinical trial source documents, both on paper and within CRIO eSource. This role requires strong protocol literacy, exceptional attention to detail, and close collaboration with Clinical Research Coordinators (CRCs), QA/QC, and EDC teams to support compliant and efficient clinical trial operations. This position plays a critical role in ensuring that source documentation accurately reflects study protocols and case report forms (CRFs), while meeting all regulatory, GCP, and sponsor expectations. Responsibilities Design, build, and maintain source documents on paper and in CRIO eSource according to study protocols and eCRFs Interpret clinical trial protocols and translate requirements into structured, compliant source documentation Ensure source documents meet GCP, regulatory, and sponsor standards Manage multiple source build and update requests weekly in a fast-paced clinical research environment Collaborate with Clinical Research Coordinators, QA/QC, and EDC teams to ensure usability and workflow alignment Communicate with EDC teams to ensure consistency between source documents and data capture systems Maintain audit readiness across all active studies through accurate and complete source builds Participate in study start-up meetings, Site Initiation Visits (SIVs), and cross-functional discussions related to source design Identify, troubleshoot, and resolve source design or workflow issues, implementing corrective actions as needed Maintain compliance with all company policies, procedures, and timelines Required Qualifications Bachelor's degree preferred or equivalent experience in clinical research, data management, or source document design Strong ability to read and interpret clinical trial protocols Excellent organizational and time-management skills Exceptional attention to detail and accuracy Strong written and verbal communication skills Ability to work independently while collaborating with cross-functional teams Preferred Qualifications Experience with computers and electronic systems Prior experience in clinical research site operations or documentation Familiarity with

GCP, FDA

regulations, and audit readiness Compensation & Benefits Health, dental, and vision insurance Paid time off and paid holidays Opportunity for growth within clinical research operations Physical Requirements Prolonged periods of sitting and working at a computer Ability to stand, bend, and reach as needed in a clinical setting

Job Type:

Full-time Pay:

$45,000.00 - $55,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Paid time off Vision insurance

Work Location:

In person