Clinical Research Associate /Monitor (CRA)

Clinical Research Associate / Monitor (CRA) — Mid-Level \| Florence, KY (Greater Cincinnati)

LBRIA

• Contract Research Organization (CRO)
• Florence, KY
• Full-Time
• Field-Based / Remote Monitoring

Are you a seasoned CRA ready to make a real impact in clinical research?

LBRIA

is a growing Contract Research Organization headquartered in Florence, KY (Greater Cincinnati area), and we're looking for a

mid-level Clinical Research Associate / Monitor

to join our expanding team. If you thrive in the field, take pride in data integrity, and are passionate about advancing clinical science — we want to hear from you.

Why LBRIA?

At LBRIA, you won't get lost in the crowd. Your team contribution will be valued.

As a Growing CRO, We Offer

• Competitive compensation commensurate with education and experience
• Day-1 vesting on our 401(k) plan with employer match
• Full employee healthcare coverage
• A collaborative team environment with opportunities to grow your clinical operations career
• Meaningful work across therapeutic, device, and combination product studies

What You'll Do

As a CRA/Monitor at LBRIA, you will serve as the

primary liaison between sponsors, investigators, and site personnel

, ensuring that clinical trials are conducted to the highest standards of quality, compliance, and participant safety.

Key Responsibilities

• Conduct independent site monitoring visits (on-site and remote/centralized) across a portfolio of clinical programs
• Verify source data, informed consent procedures, IP accountability, and site facility adequacy
• Review and maintain Investigator Site Files (ISFs) and Trial Master File (TMF) documentation
• Ensure site compliance with ICH GCP E6(R2/R3), FDA CFR requirements, and applicable SOPs and amendments
• Author and submit detailed monitoring visit reports and follow-up letters within required timelines
• Provide GCP training, EDC/randomization system orientation, and protocol support to site teams
• Support audit and inspection readiness activities

Required

What We're Looking For

• Bachelor's degree in life sciences, nursing, pharmacy, or equivalent
• 4\+ years clinical research experience; or ≥3 years in a clinical trials environment, or ≥2\+ years of independent clinical monitoring
• Thorough knowledge of ICH GCP guidelines (E6 R2/R3) and FDA CFR regulations
• Proficiency with EDC, eTMF, CTMS, Veeva Vault, and randomization systems
• Strong written communication and inter-personal skills; ability to produce clear, structured monitoring reports
• Valid driver's license

A Plus If You Have

• Experience monitoring therapeutics, device, and/or combination product studies
• Familiarity with risk-based monitoring (RBM) per ICH E6(R3)
• Prior exposure to FDA or EMA regulatory inspections

Travel \& Work Environment

This is a

field-based role

requiring

up to 100% domestic travel

(predominantly North American sites). Proficiency in remote/centralized monitoring is

required

.

How To Apply

This position is

open now

(12 June 2026)— we're actively interviewing.

Applications by email only:

[email protected]