CRA II – Sponsor Dedicated

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

📋 Description

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

• Assess the performance of sites and their staff, providing recommendations and actionable plans.

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

• Validate informed consent processes while safeguarding subject/patient confidentiality.

• Evaluate subject/patient safety, address protocol deviations, and manage pharmacovigilance concerns.

• Perform reviews of source documents and confirm the accuracy and completeness of clinical data.

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

• Inspect investigational product inventory, including storage, dispensing, and administration as necessary.

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

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

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

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

• Oversee site-level activities and communications to fulfill project objectives, deliverables, and timelines.

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

• Prepare for and participate in meetings and training sessions with investigators, sponsors, and clinical monitors.

• Facilitate audit readiness and follow-up actions post-audit.

• Support sites throughout the study lifecycle, from identification to close-out.

• Execute chart abstraction and data collection for Real World Late Phase studies.

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

• Provide training to junior staff upon request.

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

• Recommend potential sites based on local treatment trends, patient advocacy, and healthcare provider associations.

⛳️ Requirements

• Bachelor's degree or RN in a relevant field, or a comparable mix of education, training, and experience.

• 3-4 years of experience as a Clinical Research Associate (CRA).

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

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

• Experience in Immunology, Cardiology, Pulmonary Hypertension, Ophthalmology, or Lipidology.

• Exceptional communication, presentation, and interpersonal abilities.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition programs.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations provided when appropriate.