Clinical Research Associate

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

📋 Description

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

• Assess site and staff performance, providing recommendations for site-specific actions.

• Escalate significant issues to the project team and devise action plans accordingly.

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

• Evaluate site processes and perform source document reviews.

• Confirm that clinical data entered in case report forms is accurate and complete.

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

• Assist with clinical study data review and capture utilizing available hardware and software.

• Ensure compliance with electronic data capture protocols.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, administration, labeling, import, and return/release as applicable.

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

• Document monitoring activities in accordance with required project documentation.

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

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

• Manage site-level activities, communications, scope, budgets, and timelines.

• Collaborate with study site personnel and Central Monitoring Associates.

• Ensure training and compliance for assigned sites and project team members.

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

• Assist with audit readiness, preparation, and follow-up actions.

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

⛳️ 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 relevant regulatory requirements.

• 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.

• Completion of assigned training as required.

• Understanding of local requirements for real-world late phase study designs, where applicable.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and participation in a total rewards program.

• An inclusive company culture.

• Comprehensive resources including emerging technologies, data, science, and knowledge sharing.

• Exposure to various career paths and employment opportunities within a growing global organization.

• Reasonable accommodations provided when appropriate.