Clinical Research Systems Specialist

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Solaris Health

1001 - 5000 employees

Founded 2020

⚕️ Healthcare Insurance

🏥 Healthcare

🧬 Biotechnology

Healthcare Insurance • Healthcare • Biotechnology

Solaris Health is a leading national healthcare platform committed to enhancing access to specialty healthcare and continually improving patient outcomes. With over 1 million unique patients annually and 730+ providers across the country, Solaris Health operates 236+ patient offices in 14 states, focusing on innovative delivery of high-quality, value-driven care.

📋 Description

• Leads the design, implementation, and optimization of clinical research technology platforms. • Collaborates cross-functionally to translate clinical trial protocols into standardized electronic workflows. • Plays a key role in process standardization, regulatory compliance, data integrity, and research revenue optimization. • Analyzes and interprets clinical trial protocols to design, configure, and maintain electronic source documentation and study workflows. • Conducts quality assurance and validation of clinical and financial study builds prior to study activation. • Manages protocol amendments and system updates supporting regulatory compliance and operational efficiency. • Serves as primary CRIO systems resource, providing technical support to research staff. • Develops, maintains, and standardizes templates, source documents, workflows, and SOPs. • Collaborates with various departments and stakeholders during study startup and throughout the study lifecycle.

🎯 Requirements

• Bachelor's degree required • 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.

🏖️ Benefits

• N/A

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