Clinical Research Systems Specialist

GENERAL SUMMARY

The Clinical Research Systems Specialist leads the design, implementation, and optimization of clinical research technology platforms supporting study startup, documentation, financial management, compliance, and operational workflows across the network. Collaborates cross-functionally to translate clinical trial protocols into standardized electronic workflows that ensure compliant execution, accurate data, and efficient operations. Plays a key role in process standardization, regulatory compliance, data integrity, and research revenue optimization.

ESSENTIAL JOB FUNCTION/COMPETENCIES

The responsibilities and duties described in this job description are intended to provide a general overview of the position. Duties may vary depending on the specific needs of the affiliate or location you are working at and/or state requirements. Responsibilities include but are not limited to:

• Analyze and interpret clinical trial protocols, schedules of assessments, eCRFs, laboratory manuals, pharmacy manuals, imaging manuals, and sponsor documentation to design, configure, and maintain comprehensive electronic source (eSource) documentation and study workflows within the CRIO Clinical Trial Management System (CTMS).
• Design, configure, and maintain study-specific financial builds within CRIO, including negotiated budgets, visit schedules, invoiceable procedures, milestone payments, subject stipends, pass-through expenses, and reimbursement workflows to ensure accurate sponsor invoicing and revenue tracking.
• Conduct comprehensive quality assurance and validation of clinical and financial study builds prior to study activation, ensuring protocol adherence, accurate workflow logic, scheduling integrity, data capture requirements, and financial configurations.
• Manage protocol amendments and system updates by implementing sponsor revisions, maintaining version control and audit trails, and ensuring timely updates to support regulatory compliance, operational efficiency, and data integrity throughout the study lifecycle.
• Serve as the primary CRIO systems resource, providing technical support, troubleshooting complex system and build issues, coordinating with CRIO technical support, and guiding research staff on system functionality and workflow utilization.
• Develop, maintain and standardize templates, source documents, workflows, and standard operating procedures (SOPs), continuously improving best practices to drive consistency, quality, compliance, and operational efficiency across the research network.
• Collaborate with Research Operations, Regulatory Affairs, Finance, Business Development, Clinical Research Coordinators, Principal Investigators, sponsors, and vendors during study startup and throughout the study lifecycle to ensure successful implementation and maintenance of clinical research studies.
• Manage multiple concurrent projects by prioritizing study builds, meeting established timelines, and supporting new site activations, CTMS optimization initiatives, and enterprise-wide research technology implementations.
• Perform other duties as assigned.
• Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training.

CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS

• N/A

KNOWLEDGE | SKILLS | ABILITIES

• Strong understanding of ICH-GCP, FDA regulations, and ALCOA principles.
• Knowledge of clinical trial startup processes.
• Knowledge of study budgeting and clinical research financial workflows.
• Strong analytical and systems-thinking skills.
• Excellent attention to detail.
• Ability to manage multiple complex projects simultaneously.
• Strong written and verbal communication skills.
• Strong organizational and project management skills.
• Proficiency with Microsoft Office applications.
• Ability to independently analyze protocols and translate requirements into standardized electronic workflows.
• Knowledge of medical terminology, healthcare coding systems, and clinics functions.
• Knowledge of database management.

EDUCATION REQUIREMENTS

• Bachelor's degree required.

EXPERIENCE REQUIREMENTS

• Ability to independently analyze protocols and translate requirements into standardized electronic workflows.
• Experience with CTMS, eSource, EDC, or other clinical research software.
• Experience building electronic source documentation preferred.
• Experience configuring clinical research financial workflows preferred.
• Experience supporting multi-site clinical research operations preferred.

REQUIRED TRAVEL

• Occasional travel up to 10%

PHYSICAL DEMANDS

Carrying Weight Frequency

1-25 lbs. Frequent from 34% to 66%

26-50 lbs. Occasionally from 2% to 33%

Pushing/Pulling Frequency

1-25 lbs. Seldom, up to 2%

100 lbs. Seldom, up to 2%

Lifting - Height, Weight Frequency

Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33%

Floor to Chest, 26-50 lbs. Seldom: up to 2%

Floor to Waist, 1-25 lbs. Occasional: from 2% to 33%

Floor to Waist, 26-50 lbs. Seldom: up to 2%