Clinical Research Associate

• Function operationally as a member of a Project Team
• Initiate, monitor on-site and remotely, and close out study sites during study conduct
• Monitor clinical trials according to company and sponsor SOPs, GCP, ICH guidelines, and applicable regulations
• Perform monitoring activities to assess subject safety, data integrity, and quality
• Verify informed consent procedures and protocol compliance
• Review electronic or paper CRFs and subject source documentation for validity and accuracy
• Verify management and accountability of investigational product
• Prepare Monitoring Visit Reports, document findings and corrective/preventive actions, update tracking systems, and escalate issues
• Provide sites with identified issues and required action items
• Deliver site documents to eTMF or paper TMF and verify Investigator Site File maintenance
• Participate in audit or inspection preparation and follow-up activities
• Order, ship, and reconcile clinical investigative supplies when applicable
• Update CTMS and other project systems with accurate site-level information

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• Over 1 year of relevant clinical experience or relevant academic background around clinical trial or clinical development activities
• Ability to work in a fast-paced environment with changing priorities
• Basic medical terminology and science associated with assigned drugs and therapeutic areas
• Understanding of Good Clinical Practice regulations and ICH guidelines
• Ability to work independently and in a team matrix organization
• Strong written and verbal communication skills
• Fluent in English and German
• Excellent organizational skills
• Technology savvy with good software and computer skills
• Ability and willingness to travel up to 60-80%, including overnight and abroad travel if applicable

• Competitive compensation package
• Comprehensive benefits
• Opportunity for personal and professional growth
• Collaborative and innovative work environment
• Opportunity to make a difference in the lives of patients