Lead Clinical Research Systems Analyst

Wexner Medical Center; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Wexner Medical Center is seeking a Clinical Research Informatics Specialist to oversee daily operation of CRI-supported applications and manage user access and audits. You will help implement modules within Clinical Research Enterprise systems and ensure regulatory compliance.

Collaborate with system vendors, clinical research operations, and informatics engineers to validate new modules, update protocols, and develop training materials.

Qualifications

• Four to eight years of relevant clinical experience in a clinical research setting with subject matter expertise in clinical trial workflows.
• Experience with clinical trial data requirements, regulatory affairs, CRF development, and protocol development.
• Knowledge of business intelligence tools and report formatting applications (Excel, Tableau, Power BI).
• IT experience and familiarity with clinical trials or research environments are valuable.

Responsibilities

• Oversee CRI-supported applications and manage access controls.
• Coordinate with vendors, clinical research ops, and informatics engineers to test and implement modules.
• Develop validation documentation and SOPs to ensure FDA 21 CFR Part 11 compliance.
• Lead cross-functional collaboration across the medical center's clinical research enterprise.

Skills

Clinical trials mgmt

Clinical research ops

Regulatory affairs

Protocol development

CRF development

Data requirements

BI tools (Excel/Tableau/Power BI)

Communication skills

Education

Bachelor's degree in health science

Advanced degree preferred

Tools

Excel

Tableau

Power BI

Job description

Wexner Medical Center is seeking a Clinical Research Informatics Specialist to oversee daily operation of CRI-supported applications and manage user access and audits. You will help implement modules within Clinical Research Enterprise systems and ensure regulatory compliance.

Collaborate with system vendors, clinical research operations, and informatics engineers to validate new modules, update protocols, and develop training materials.