Clinical Research Associate

This is a fully remote position, open to applicants in Denmark.

📋 Description

• Conduct site qualification, initiation, interim monitoring, site management activities, and close-out visits, whether on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess the performance of sites and site personnel, providing recommendations for site-specific actions.

• Report significant issues to the project team and formulate action plans accordingly.

• Verify the informed consent process and safeguard the confidentiality of subjects/patients.

• Evaluate subject/patient safety, identify protocol deviations or violations, and address pharmacovigilance concerns.

• Conduct reviews of source documents and validate clinical data documented in case report forms.

• Resolve queries both remotely and on-site, offering guidance to site staff.

• Ensure compliance with electronic data capture standards.

• Oversee the inventory, reconciliation, storage, security, dispensing, and administration of investigational products as necessary.

• Review Investigator Site Files and ensure they are reconciled with the Trial Master File.

• Document monitoring activities through necessary letters, reports, logs, and project documentation.

• Assist in strategies for subject/patient recruitment, retention, and awareness.

• Monitor observations, site status, and action items until resolution.

• Manage site-level activities and communications to achieve project goals, deliverables, and timelines.

• Serve as the primary liaison with study site personnel or collaborate with a Central Monitoring Associate.

• Ensure that assigned sites and project-specific site team members receive training and maintain compliance.

• Prepare for and participate in investigator and sponsor meetings.

• Engage in global clinical monitoring, project staff meetings, and clinical training sessions.

• Support audit readiness and follow-up actions post-audit.

• Stay informed about relevant guidelines, regulations, and company SOPs, completing all required training.

⛳️ Requirements

• Bachelor's degree or RN in a relevant field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other pertinent regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Prior experience in monitoring.

• Outstanding communication, presentation, and interpersonal abilities.

• Proficiency in both Danish and English.

• A good understanding of Swedish and Norwegian is preferred.

• Willingness to travel up to 75% of the time regularly.

• Capability to perform cross-border monitoring in the Nordics if necessary.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• A culture that values inclusivity.

• Reasonable accommodations available when appropriate.