Clinical Research Associate

1w1 week ago

QuidelOrtho

Athens, US · Full-time · $80,000 – $120,000

About this role

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company. Expertise covers immunoassay, molecular testing, clinical chemistry, and transfusion medicine. The Clinical Research Associate writes clinical protocols and monitors trials for new IVD investigational products including instruments and test devices.

Daily responsibilities include ensuring clinical study data accuracy via source verification, query initiation, and resolution. Monitors sites to follow clinical study protocol, GCP, and applicable regulations. Conducts study site selection, qualification, training, start-up, and close-out activities.

Supports Institutional Review Board submissions and acts as primary contact between sites and sponsor. Assists in-house team with study supplies assembly, instrument configuration, inventory, and Trial Master File maintenance. Ensures proper handling, storage, and shipment of clinical specimens and materials.

Our culture prioritizes team members first, supporting happiness, inspiration, and engagement. Builds meaningful connections linking employee happiness to business success. Join the mission to transform diagnostics into a healthier future for all.

Requirements

Knowledge of Good Clinical Practice (GCP)
Familiarity with U.S. QSR and ISO9000 regulations
Understanding of FDA regulations for clinical research
Experience in clinical trial site monitoring and management
Proficiency in source data verification and query resolution
Ability to manage clinical study materials and specimens
Skills in Trial Master File maintenance

Responsibilities

Write clinical protocols for beta-site and formal clinical studies
Identify, set up, and monitor clinical trials for new IVD investigational products
Ensure clinical study data are accurate via source verification, query initiation, and resolution
Ensure sites follow clinical study protocol, GCP, and all applicable regulations
Conduct study site selection, qualification, training, start-up, and close-out
Support Institutional Review Board/Ethics Committee submissions
Maintain Trial Master Files for assigned clinical studies
Ensure compliance with U.S. QSR, ISO9000 regulations, GCP, and FDA regulations