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, and close-out visits, either on-site or remotely.

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

• Assess site and staff performance while communicating or escalating critical issues as needed.

• Confirm informed consent, maintain subject confidentiality, ensure safety, and uphold clinical data integrity and protocol compliance.

• Perform source document reviews and validate the accuracy and completeness of clinical data.

• Address data queries and confirm compliance with electronic data capture processes.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, and returns when applicable.

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

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

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

• Monitor observations, action items, site status, deliverables, budgets, and timelines.

• Serve as a liaison with study site personnel, ensuring that site teams are adequately trained and compliant.

• Participate in investigator, sponsor, project, and clinical training meetings.

• Aid in audit readiness, preparation, and follow-up actions.

• For Real World Late Phase: provide comprehensive site support throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior personnel, identify out-of-scope activities, and recommend potential sites based on local insights.

⛳️ Requirements

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

• Oncology experience is a plus.

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

• Proficiency in computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal skills.

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

• Working knowledge of relevant regulations and company SOPs/processes.

• Must complete necessary training as required.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations when appropriate.