Remote Ophthalmology Senior CRA II

FTINC Fortrea Inc.; North Carolina; Vor Ort; USD 125.000 - 142.000; Vollzeit

Zusammenfassung

Fortrea Inc. on the East Coast is seeking an Ophthalmology Senior Clinical Research Associate (CRA) with 4+ years of monitoring experience to oversee site performance and data quality in ophthalmology trials.

This role emphasizes clinical judgement, regulatory adherence, and proactive issue resolution. You will conduct routine and risk-based monitoring visits, manage CRFs and SAE reporting, and collaborate with cross-functional teams to ensure protocol compliance.

Qualifikationen

• University or college degree in a related allied health field or nursing licensure.
• 5+ years of Clinical Monitoring experience.
• Oncology experience, early phase preferred.
• 30-50% overnight travel.

Aufgaben

• Monitor study sites: routine visits, close-out, file upkeep, pre-study/initiation visits, liaison with vendors.
• Oversee site management per project plans.
• General on-site monitoring.
• Ensure staff have materials/instructions to enter patients safely.
• Ensure patient protection via informed consent and protocol compliance.
• Verify data integrity on CRFs and other data tools.
• Monitor data for missing or implausible data.
• Manage registry activities per project plans.
• Perform feasibility work when requested.
• SAE reporting and follow-up.
• CRF review, query generation/resolution per guidelines.
• Assist with training of new employees.
• Coordinate clinical projects as Local Project Coordinator (with supervision).
• Other duties as assigned.

Kenntnisse

Clinical Monitoring

Ophthalmology

Regulatory Compliance

SAE reporting

Ausbildung

Bachelor's degree in a related field

Jobbeschreibung

Fortrea Inc. on the East Coast is seeking an Ophthalmology Senior Clinical Research Associate (CRA) with 4+ years of monitoring experience to oversee site performance and data quality in ophthalmology trials.

This role emphasizes clinical judgement, regulatory adherence, and proactive issue resolution. You will conduct routine and risk-based monitoring visits, manage CRFs and SAE reporting, and collaborate with cross-functional teams to ensure protocol compliance.