Clinical Research Associate II / Senior Clinical Research (CRA) (m/w/x) Germany
CTI Clinical Trial and Consulting Services · BW, DE
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About the Role
Serve as the main CTI contact for assigned study sites, conducting various site visits and assisting with study start-up activities. You will collect, review, and track essential documents, participate in training, and attend meetings. Responsibilities include creating enrollment strategies, ensuring proper handling of investigational product, performing site management, conducting remote monitoring, and utilizing systems to track subject status and data. You will also assist with project-specific activities as a member of the Project Team.
Responsibilities
- Serve as main CTI contact for assigned study sites
- Conduct site visits (pre-study, site initiation, interim monitoring, and close-out) and complete deliverables within timelines, adhering to regulatory requirements, SOPs, and ICH GCP
- Assist with or oversee study start-up activities, including feasibility, pre-study activities, and site selection
- Collect, review, and track essential/regulatory documents
- Participate in and complete all general and study specific training as required
- Participate in investigator, client, and project team meetings; may include presentations
- Create and implement subject enrollment strategies for assigned study sites
- Ensure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
- Assist with project-specific activities as member of Project Team
Requirements
- 3 - 5 years clinical research experience as a CRA or related profession in Germany
- Independent monitoring experience in Germany
- Life science background
- Excellent knowledge in ICH-GCP and regulatory requirement
- Fluent (at least Level B2) in spoken and written language German and English
Experience Level
- 3-5 years
Benefits
- Structured mentoring program
- Leadership development courses
- Dedicated training department
- Support for ongoing education
- Hybrid work opportunities
- CTI Cares program for community involvement
About the Company
- CTI invests in your professional growth through structured mentoring, leadership development, and a dedicated training department.
- Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people and supports work-life balance.
- Your work directly contributes to advancing medicine and developing life-changing treatments for patients.
- CTI is committed to moving medicine forward and making a difference for those who need it most.