CRAII - Sponsor-dedicated (Sweden)

Overview

Conduct clinical research associate activities for a sponsor-dedicated role in Sweden, supporting study sites from qualification through close-out while ensuring regulatory, ICH-GCP and protocol compliance.

What you'll do

• Perform site qualification, initiation, monitoring, management and close-out visits on-site or remotely.
• Evaluate site performance, identify risks and escalate serious issues with action plans.
• Review source documents, medical records, case report forms and electronic data capture compliance.
• Verify informed consent, investigational product handling, patient safety and clinical data integrity.
• Maintain Investigator Site Files and reconcile them with Trial Master Files.
• Support recruitment, retention, site communications, documentation and query resolution.
• Prepare for audits and investigator or sponsor meetings, and support required follow-up actions.

What you'll need

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice, ICH Guidelines and applicable regulatory requirements.
• Good computer skills and ability to use new technologies.
• Strong communication, presentation and interpersonal skills.
• Ability to travel up to 75% regularly.

Details

• Location: Sweden.
• Work may be performed on-site or remotely.
• Travel required: up to 75% regularly.