CRA II

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

📋 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, study protocols, and company SOPs/processes.

• Assess the performance of sites and site personnel, providing tailored recommendations.

• Address serious issues promptly and formulate corresponding action plans.

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

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

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

• Ensure compliance with electronic data capture protocols.

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

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

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

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

• Monitor observations, site status, and action items through to resolution.

• Coordinate site-level activities and communication to achieve project goals, deliverables, budgets, and timelines.

• Serve as a liaison with study site staff, ensuring training and compliance among assigned sites and project team members.

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

• Aid in audit preparedness, preparation, and follow-up activities.

• For Real World Late Phase: assist sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local country personnel, train junior staff, recognize 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 applicable regulatory standards.

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

• Outstanding communication, presentation, and interpersonal abilities.

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

• Solid understanding of relevant regulations and company SOPs/processes.

• Ability to execute clinical monitoring and site management tasks either on-site or remotely.

• For Real World Late Phase: awareness of local requirements for real-world late phase study designs.

• For Real World Late Phase: experience or capability in chart abstraction and data collection.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive company culture.

• Reasonable accommodations when necessary.