Clinical Research Associate

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

📋 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, and protocol compliance.

• Assess the performance of sites and their staff, communicate critical issues, and formulate action plans.

• Confirm informed consent, maintain subject confidentiality, ensure safety, uphold clinical data integrity, and address protocol deviations and pharmacovigilance concerns.

• Evaluate site processes and carry out reviews of source documents and medical records.

• Validate clinical data in case report forms and resolve queries both remotely and on-site.

• Utilize hardware and software to assist in the review and capture of clinical study data.

• Ensure compliance with electronic data capture standards.

• Conduct inventory, reconciliation, storage, dispensing, and administration checks of investigational products.

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

• Document monitoring activities and log observations and action items into tracking systems.

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

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

• Serve as a liaison with project site personnel, ensuring assigned sites and team members receive adequate training and remain compliant.

• Prepare for and participate in investigator and sponsor meetings as well as clinical training sessions.

• Offer guidance on audit preparedness and assist with audit preparation and follow-up.

• Mentor junior CRAs and conduct training/sign-off visits as needed.

• Potentially undertake clinical operations lead tasks under supervision.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Understanding of Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Prior monitoring experience in Germany.

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

• Outstanding communication, presentation, and interpersonal abilities.

• Basic critical thinking skills.

• Fluent in both English and German.

• Willingness to manage travel requirements of up to 75% regularly.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged leadership.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• A culture that promotes inclusivity.

• Reasonable accommodations provided when suitable.