Position Summary

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

The Clinical Data 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.

In addition, this role is responsible for reading and understanding Clinical Trial Agreements (CTAs) to ensure contractual and protocol requirements are accurately reflected in study systems, performing accurate and timely data entry across clinical systems, and reviewing CTMS templates for accuracy, completeness, and compliance prior to deployment.

Key Responsibilities

• CTA Interpretation: Read, interpret, and apply Clinical Trial Agreement (CTA) terms to ensure protocol, budget, and system requirements are accurately reflected in source documentation and CTMS templates.
• Data Entry: Perform accurate and timely data entry into CTMS and related clinical systems, ensuring data integrity and consistency across the network.
• CTMS Template Review: Review CTMS templates for accuracy, completeness, and alignment with protocol and regulatory requirements prior to deployment.
• Source Development: Design and build standardized source document templates that align with 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 and data entry by implementing network-wide standards.
• Site Support: Act as primary point of contact for sites regarding source management, data entry, and technical troubleshooting across the network.
• Collaboration: Work closely with the CTMS team and Clinical Operations to ensure all templates and data reflect the most current regulatory and study-specific requirements.

Required Qualifications

• Education: Associate’s or Bachelor's degree in healthcare, life sciences, or equivalent experience
• Experience: 3-5 years of experience in clinical research, regulatory affairs, or study start up (site or central level preferred)
• Technical Skills/Systems Experience: Experience with CTMS, eRegulatory systems, proficiency in Microsoft platforms, familiarity with IRB submission platforms
• Other Requirements (e.g., ability to travel, schedule flexibility, etc.): Strong organizational skills with attention to detail, ability to manage multiple studies and deadlines simultaneously, ability to work cross-functionally in a fast-paced environment

Preferred Qualifications

• SOCRA, CCRC, CRA, CP, or similar certifications preferred but not required.

Core Competencies / Skills

• Strong Communication and cross-functional collaboration
• Attention to detail and regulatory compliance
• Time management and ability to prioritize competing deadlines
• Problem-Solving and proactive follow-up
• Adaptability in a fast-paced clinical research environment
• Commitment to quality and patient-centered research