Clinical Research Associate II

Job Responsibilities

• Performs site qualification, initiation, interim monitoring, and close-out visits ensuring regulatory compliance.
• Evaluates site and staff performance, providing recommendations and escalating issues.
• Maintains knowledge of ICH/GCP guidelines and company SOPs.
• Verifies informed consent documentation and subject safety.
• Conducts Source Document Reviews, CRF data verification, and query resolution.
• Monitors investigational product inventory and storage.
• Reviews Investigator Site Files (ISFs) and reconciles with Trial Master Files (TMFs).
• Documents activities and coordinates with study sites and sponsors.
• Supports subject recruitment, retention, and awareness strategies.
• Manages assigned sites and project activities to meet objectives and timelines.
• Attends and participates in meetings and prepares for Investigator Meetings.
• Maintains audit readiness standards and supports audit preparation.

Qualifications

• Bachelor’s degree or RN in a related field, or equivalent experience.
• Two years of monitoring experience required.
• Good computer skills and ability to adapt to new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Able to manage up to 75% travel for required site visits.