CTMS & Source Data Specialist

Elite Clinical Network; United States; On-site; USD 55,000 - 85,000; Full time

Job summary

Elite Clinical Network is seeking a Clinical Data Specialist to act as a key liaison between Contracts and Budgets, Clinical Operations, sites, and the CTMS team to align protocol requirements, source documentation, and system data capture standards.

You will develop, standardize, and integrate source documentation across the research network, support regulatory readiness, and optimize systems while ensuring accurate data entry and governance across studies.

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
• 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

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

Skills

CTA interpretation

Data entry

CTMS template review

Source development

System integration

Quality & compliance

Site support

Collaboration

Attention to detail

Education

Associate’s or Bachelor’s degree in healthcare, life sciences, or equivalent experience

Tools

CTMS

eRegulatory systems

Microsoft Office

IRB submission platforms

Job description

Elite Clinical Network is seeking a Clinical Data Specialist to act as a key liaison between Contracts and Budgets, Clinical Operations, sites, and the CTMS team to align protocol requirements, source documentation, and system data capture standards.

You will develop, standardize, and integrate source documentation across the research network, support regulatory readiness, and optimize systems while ensuring accurate data entry and governance across studies.