Clinical Research Associate

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely
• Ensure regulatory, ICH-GCP/GPP and protocol compliance
• Evaluate site and site staff performance, communicate serious issues, and develop action plans
• Verify informed consent, subject confidentiality, safety, clinical data integrity, protocol deviations and pharmacovigilance issues
• Assess site processes and conduct source document review and medical-record review
• Verify clinical data in case report forms and resolve queries remotely and on site
• Use hardware and software to support clinical study data review and capture
• Verify electronic data capture compliance
• Perform investigational product inventory, reconciliation, storage, dispensing and administration checks
• Review Investigator Site Files and reconcile them with the Trial Master File
• Document monitoring activities and enter observations and action items into tracking systems
• Support subject/patient recruitment, retention and awareness strategies
• Manage site-level activities and communication to meet project objectives, deliverables and timelines
• Act as liaison with project site personnel and ensure assigned sites and team members are trained and compliant
• Prepare for and attend investigator and sponsor meetings and clinical training sessions
• Provide guidance on audit readiness and support audit preparation and follow-up
• Mentor junior CRAs and perform training/sign-off visits as assigned
• Potentially perform clinical operations lead tasks under supervision

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Previous monitoring experience in Germany
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Basic level of critical thinking skills
• Fluency in English and German
• Ability to manage required travel of up to 75% on a regular basis

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations when appropriate