Clinical Research Associate II: Remote Monitoring & Data Integrity

Premier Research International

United States

On-site

USD 70,000 - 95,000

Full time

3 days ago

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Job summary

Premier Research International is seeking a Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team in the United States. You will monitor sponsor sites, ensure data integrity and patient safety according to ICH GCP/ISO14155 guidelines, and manage site visits across remote or on-site modes.

The role requires an undergraduate degree in clinical/science/health fields and 2+ years of CRA experience, with CRA training completed.

Qualifications

Undergraduate degree or international equivalent in clinical, science, or health-related field; licensed health-care professional or equivalent work experience required
2+ years' experience in clinical trials and proven CRA experience; CRA training completed

Responsibilities

Delivers quality, timely monitoring reports for sponsor approval per monitoring plan timelines
Maintains TMF/eTMF and site documents per ICH GCP/ISO14155 guidelines
Monitors data integrity and patient safety across sites (remote, onsite or other approved mode)
Plans day-to-day monitoring activities and coordinates site visits (qualification, initiation, interim and close-out)
Manages query resolution with sites and data management
Maintains contact with study teams and management and ensures timely communication and documentation