CRA II – Sponsor-dedicated

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

📋 Description

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

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

• Assess the performance of sites and site personnel, recommending specific actions as necessary.

• Communicate serious issues promptly and formulate comprehensive action plans.

• Confirm informed consent, uphold subject/patient confidentiality, safety, clinical data integrity, and compliance with protocols.

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

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

• Examine investigational product inventory, including its storage, security, dispensing, administration, and reconciliation.

• Review and reconcile Investigator Site Files with Trial Master Files.

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

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

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

• Serve as a liaison with study site personnel to ensure compliance and training for the site/project team.

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

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

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

⛳️ 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.

• Exceptional communication, presentation, and interpersonal abilities.

• Capability to manage travel requirements of up to 75% regularly.

• Understanding of ICH/GCP Guidelines, applicable guidance, relevant regulations, and company SOPs/processes.

• Ability to execute site qualification, initiation, monitoring, management, and close-out tasks.

• For Real World Late Phase: knowledge of local requirements related to real world late phase study designs.

• For Real World Late Phase: proficiency in chart abstraction and data collection.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• A culture of inclusivity.

• Reasonable accommodations when appropriate.