Clinical Research Associate /Monitor (CRA)

Jobs
Written By Mary Skelly

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

What We're Looking For

Required:

  • 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: jobs@lbria.com

Mary Skelly