Clinical Research Associate – Single Sponsor

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

📋 Description

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

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, and protocol requirements.

• Assess site and staff performance, communicate critical issues, and formulate action plans.

• Validate informed consent, maintain subject confidentiality, ensure safety, and uphold clinical data integrity.

• Evaluate site processes and perform source document and medical record reviews.

• Confirm clinical data accuracy in case report forms and facilitate query resolution.

• Assist in clinical study data review, capture, and ensure electronic data capture compliance.

• Oversee investigational product inventory management, reconciliation, storage, dispensing, and administration checks.

• Review Investigator Site Files and ensure they match the Trial Master File.

• Record monitoring activities and track observations and action items until resolution.

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

• Manage site-level activities, communications, project goals, deliverables, and timelines.

• Collaborate with study site personnel to ensure site team training and adherence to compliance.

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

• Contribute to audit readiness, preparation, and follow-up actions.

• Stay updated on ICH/GCP regulations and company SOPs; complete all assigned training.

⛳️ 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 relevant regulatory standards.

• Prior monitoring experience in Austria.

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

• Proficiency in both German and English.

• Exceptional communication, presentation, and interpersonal abilities.

• Capacity to manage necessary travel for monitoring visits within Austria.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• A culture of total self, promoting authenticity and inclusion.

• Initiatives focused on diversity, equity, and belonging.