Clinical Research Associate II

Job Responsibilities

• Performs site qualification, initiation, interim monitoring, and close-out visits ensuring compliance with ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol.
• Evaluates site and staff performance, providing recommendations and escalating issues to the project team.
• Maintains knowledge of ICH/GCP Guidelines, regulations, and company SOPs.
• Verifies informed consent documentation, subject safety, and clinical data integrity.
• Conducts Source Document Reviews, CRF data verification, and remote/on-site query resolution.
• Monitors investigational product inventory, reconciles IP, and ensures proper labeling and storage.
• Reviews Investigator Site Files (ISFs), reconciles with TMFs, and ensures compliance with local guidelines.
• Documents activities and coordinates with study sites and project teams.
• Attends and participates in meetings, prepares for Investigator Meetings, and supports audit readiness.

Qualifications

• Bachelor’s degree or RN in a related field, or equivalent experience.
• 12 months 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 on a regular basis.