Clinical Research Source/CTMS Specialist

Position Summary

The Clinical Research Source/CTMS Specialist is responsible for the development, standardization, and integration of clinical research source documentation. This role ensures high-quality, compliant source documentation across the research network while supporting system optimization, regulatory readiness, and operational efficiencies.

The Specialist serves as a key liaison between Clinical Operations, sites, and the CTMS team to ensure seamless alignment between protocol requirements, source documentation, and system data capture standards.

Key Responsibilities

• Source Development: Design and build standardized source document templates that align with the protocol requirements and CTMS data fields.
• System Integration: Ensure that as CTMS templates are built, corresponding source documents are simultaneously developed to prevent data silos or compliance gaps.
• Quality \& Compliance: Directly address and mitigate audit findings related to source management by implementing network-wide standards.
• Site Support: Act as primary point of contact for sites regarding source management issues and technical troubleshooting across the network.
• Collaboration: Work closely with the CTMS team and Clinical Operations to ensure all templates reflect the most current regulatory and study-specific requirements.

Required Qualifications

• Experience: 3-5 years in clinical research, specifically focused on CTMS administration, data management, or clinical site monitoring.
• Technical Skills/Systems Experience: Proficiency in CTMS platforms and electronic source (eSource) software. Experience in template design or database logic is highly preferred.
• Regulatory Knowledge: Deep understanding of GCP, ICH guidelines, and FDA requirements regarding source documentation and ALCOA\+ principles.
• Attention to Detail: Proven ability to translate complex clinical protocols into user-friendly, compliant site documentation.

Preferred Qualifications

• Licenses/Certifications: CCRC, CRA, CP, or similar preferred but not required.

Core Competencies / Skills

• Communication
• Problem-Solving
• Leadership
• Strong written and verbal communication with a focus on clarity, accuracy, and professionalism