Experienced Clinical Research Associate - Sponsor Dedicated

Job Responsibilities

• Performs site qualification, initiation, interim monitoring, and close-out visits ensuring regulatory compliance.
• Evaluates site and staff performance, and recommends actions.
• Maintains knowledge of ICH/GCP guidelines and company SOPs.
• Verifies informed consent documentation and subject safety.
• Conducts Source Document Reviews, verifies CRF accuracy, and resolves queries.
• Monitors IP inventory, reconciles, and ensures proper storage and administration.
• Reviews and reconciles Investigator Site Files (ISFs) with Trial Master Files (TMFs).
• Documents activities and coordinates with project teams.
• Supports subject recruitment, retention, and awareness strategies.
• Enters data into tracking systems and prepares for meetings.
• Manages site-level activities and communication to meet project objectives.
• Attends and participates in meetings and training sessions.
• Ensures audit readiness and follows up on required actions.
• Provides guidance on audit standards and prepares for audits.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulations.
• Good computer skills and ability to adapt to new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage up to 75% travel on a regular basis.