About the role
What You'll Do:
Serve as main CTI contact for assigned study sites
Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable 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
What You'll Bring:
3 - 5 yearsclinical research experience as a CRA or related professionin Germany incl. 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
About CTI
Advance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.
Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website () or from our verified LinkedIn page.
Please Note
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process
Originally posted on Himalayas