CRA II – Sponsor-dedicated

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

📋 Description

• Conduct site qualification, initiate sites, monitor progress, manage site activities, and perform close-out visits.

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

• Report significant issues to the project team and create actionable plans.

• Ensure informed consent processes, maintain subject/patient confidentiality, and uphold safety and clinical data integrity.

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

• Address queries both remotely and on-site within specified timelines.

• Confirm adherence to electronic data capture requirements.

• Oversee the inventory, reconciliation, storage, dispensing, and administration checks of investigational products.

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

• Document activities with confirmation letters, follow-up letters, trip reports, and communication logs.

• Aid in the recruitment, retention, and awareness strategies for subjects/patients.

• Monitor observations, track ongoing statuses, and resolve action items.

• Manage site-level activities, communications, project objectives, deliverables, and timelines.

• Serve as a liaison with study site personnel, ensuring site team training and compliance.

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

• Assist in maintaining audit readiness and following up on audit actions.

• Provide support to sites throughout the lifecycle of the real-world late-phase study.

• Conduct chart abstractions and collect data.

• Collaborate with sponsor affiliates, medical science liaisons, and local country staff.

• Train junior staff members as requested.

• Identify and communicate activities that fall outside the project scope.

• Propose potential sites based on local treatment patterns, patient advocacy, and healthcare professional associations.

⛳️ Requirements

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

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

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

• Strong communication, presentation, and interpersonal skills.

• Capacity to manage required travel of up to 75% regularly.

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

• Ability to perform clinical monitoring and site management tasks both on-site and remotely.

🏝️ 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.

• An inclusive company culture.

• Chance to collaborate with colleagues globally.