Clinical Research Associate (level dependent on experience)

CTI Clinical Trial and Consulting Services; France; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

CTI Clinical Trial and Consulting Services seeks a Clinical Research Associate to oversee monitoring activities at assigned study sites in Germany. You will ensure quality deliverables and regulatory compliance while coordinating with cross‑functional teams.

The role involves site visits (PSV, SIV, IMV, COV), regulatory documentation, and ongoing collaboration with project teams. 3‑5 years CRA experience and fluent English are required.

Qualifikationen

• 3 - 5 years clinical research experience as a CRA or related profession in Germany, incl. independent monitoring.
• Life science background.
• Fluent English (B2) in speech and writing.

Aufgaben

• Serve as main CTI contact for assigned study sites.
• Conduct site visits and complete deliverables per Monitoring Plan.
• Assist with startup activities and site selection.
• Collect, review and track essential regulatory documents.
• Monitor site status and report to the Clinical Project Manager.

Kenntnisse

CRA experience

Independent monitoring

ICH-GCP knowledge

English proficiency

Life science background

Jobbeschreibung

• 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 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 years clinical research experience as a CRA or related profession in 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 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 (www.ctifacts.com) 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