Clinical Research Associate / Monitor (CRA)

About the Role and Company

LBRIA, a growing Contract Research Organization headquartered in Florence, KY (Greater Cincinnati area), is seeking a mid-level Clinical Research Associate / Monitor. This full-time position is field-based with remote monitoring responsibilities. As a key member of the team, you will ensure excellence in clinical trial conduct, data integrity, and participant safety across diverse therapeutic, device, and combination product studies.

Key Responsibilities

• Perform independent monitoring visits both onsite and remotely for various clinical study sites.
• Verify accuracy of source data, adherence to informed consent processes, investigational product accountability, and site facilities.
• Maintain and audit Investigator Site Files (ISF) and Trial Master File (TMF) documentation.
• Ensure study site compliance with ICH GCP E6(R2/R3), FDA CFR, SOPs, and regulatory amendments.
• Prepare and submit comprehensive monitoring reports and follow-up correspondence within stipulated timelines.
• Deliver GCP training and orientation on electronic data capture (EDC), randomization systems, and protocol guidance to site personnel.
• Assist in audit and inspection readiness activities.

Candidate Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a closely related field.
• Minimum of 4 years clinical research experience; or at least 3 years in clinical trials or 2+ years of independent monitoring.
• In-depth understanding of ICH GCP guidelines (E6 R2/R3) and FDA CFR rules.
• Proficiency with EDC systems, electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), Veeva Vault, and randomization tools.
• Strong written communication and interpersonal skills, enabling clear and structured monitoring reports.
• Valid driver's license is mandatory.

Preferred Qualifications

• Experience monitoring studies involving therapeutics, medical devices, or combination products.
• Knowledge of risk-based monitoring approaches in line with ICH E6(R3).
• Previous involvement with FDA or EMA regulatory inspections.

Work Environment and Travel

This position demands up to 100% domestic travel across North America and requires adeptness in both onsite and remote monitoring methods.

Benefits and Company Highlights

• Competitive salary aligned with education and experience.
• Immediate vesting in company 401(k) plan with employer matching contributions.
• Comprehensive health insurance coverage for employees.
• Supportive and collaborative workplace fostering career growth in clinical operations.
• Engagement in meaningful research impacting therapeutics and device development.

Application Details

The opening is currently available with active interviews underway. Applications are accepted via email directly to the company.