Clinical Research Associate II – Sponsor-dedicated

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

📋 Description

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

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess the performance of sites and site staff, offering tailored recommendations.

• Address critical issues and formulate action plans.

• Verify informed consent procedures and maintain the confidentiality of subjects/patients.

• Evaluate subject safety, the integrity of clinical data, protocol deviations/violations, and pharmacovigilance matters.

• Conduct reviews of source documents to confirm the accuracy and completeness of clinical data.

• Resolve queries both remotely and on-site within established timelines.

• Ensure compliance with electronic data capture standards.

• Oversee investigational product inventory, including reconciliation, storage, dispensing, and administration when applicable.

• Review Investigator Site Files and ensure reconciliation with Trial Master Files.

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

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

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

• Manage site-level operations and communications to achieve project objectives, deliverables, and timelines.

• Collaborate with study site personnel to ensure that assigned sites and project team members are properly trained and compliant.

• Participate in investigator, sponsor, global monitoring, and clinical training meetings.

• Facilitate audit readiness, preparation, and follow-up actions.

• For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with Sponsor affiliates, medical science liaisons, and local country staff, train junior staff when needed, identify out-of-scope activities, and recommend potential sites based on local knowledge.

⛳️ Requirements

• A Bachelor’s degree or RN in a relevant field, or a combination of education, training, and experience that is equivalent.

• Experience in oncology is a plus.

• Familiarity with Good Clinical Practice/ICH Guidelines and other applicable regulatory standards.

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

• Exceptional communication, presentation, and interpersonal abilities.

• Capability to manage travel requirements of up to 65-75% on a regular basis.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive organizational culture.

• Reasonable accommodations, when appropriate, to assist employees or applicants in performing essential job functions.