We are currently recruiting for the CRA sponsor -dedicated to be home-based on the south part of Germany. This is an excellent permanent opportunity where one can develop their skill set further and work on exciting studies of a well-known and established pharmaceutical company.
- Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements.
- Evaluate overall performance of site and site staff.
- Ensure compliance and understanding of study requirements by site contacts.
- Ensure adequate enrolement.
- Apply knowledge to resolve basic site issues.
- Identify and escalate more complex issues.
- Interpret data to identify protocol deviations or major risks data integrity.
- Understand and interpret protocol and regulations to ensure sites are inspection-ready.
- Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines.
- Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
- Review and verify case report forms and other clinical data for completeness and accuracy.
- Monitor patient safety, identify and address any protocol deviations.
- Recommend appropriate follow-up responses, generate queries and manage resolutions with site personnel.
- Participate in the identification and selection of investigators and clinical sites.
- Maintain project tracking systems as required.
- Complete assigned training programs and apply learning.
- Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations.
The ideal candidate will need the following experience / skills to be considered:
• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• 0 – 2 years prior clinical research/monitoring experience
• Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements
• Strong organizational skills
• Must demonstrate good computer skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Heavy travel required (up to 60%)
• Fluency in German and a high level of English language are required