CRA II/Sr CRA, Austria

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

📋 Description

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

• Ensure adherence to regulatory standards, ICH-GCP/GPP, and protocol requirements.

• Assess site and site staff performance and suggest site-specific recommendations.

• Raise significant issues and create action plans to address them.

• Verify the informed consent process and uphold subject/patient confidentiality.

• Evaluate subject/patient safety, protocol deviations/violations, and pharmacovigilance matters.

• Carry out source document reviews and validate clinical data in case report forms.

• Resolve queries both remotely and on-site while guiding site staff.

• Confirm compliance with electronic data capture standards.

• Manage investigational product inventory, reconciliation, and storage/security evaluations.

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

• Document monitoring activities and maintain tracking systems for oversight.

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

• Oversee site-level activities and communications to achieve project goals, deliverables, and timelines.

• Act as the liaison with study site personnel, ensuring training and compliance with site/project teams.

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

• Facilitate audit readiness, preparation, and follow-up actions.

• Complete required training and stay informed about relevant guidance, regulations, and SOPs.

⛳️ Requirements

• A 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.

• Prior monitoring experience in Austria is mandatory.

• Previous monitoring experience in Germany and Switzerland is preferred.

• Strong computer proficiency and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Proficiency in both German and English.

• Capability to manage necessary travel for monitoring visits across Austria, Germany, and Switzerland.

🏝️ 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 organizational culture.

• Reasonable accommodations available when appropriate.