Clinical Research Associate II / Senior Clinical Research (level dependent on experience)

CTI Clinical Trial and Consulting Services; City; Hybrid; GBP 39,000 - 64,000; Full time

Benefits offered by this job

Hybrid work opportunities

Mentoring program

Leadership development

Job summary

CTI Clinical Trial and Consulting Services is seeking a CRA with 3–5 years of clinical research experience in Germany and strong ICH-GCP knowledge. You will monitor sites, manage regulatory documents, and support study start-up activities within a hybrid work model.

Strong German and English communication skills (B2) are required, with life science background and regulatory compliance as pillars of the role.

Qualifications

• 3–5 years clinical research experience as a CRA or related profession in Germany, incl. independent monitoring.
• Life science background.
• Excellent knowledge in ICH-GCP and regulatory requirements.
• Fluent (at least Level B2) in spoken and written German and English.

Responsibilities

• Serve as main CTI contact for assigned study sites.
• Conduct site visits (PSV, SIV, IMV, COV) and deliver high-quality deliverables on time.
• Assist with feasibility, pre-study activities and site selection.
• Collect, review and track essential/regulatory documents.
• Participate in trainings and in investigator, client and project team meetings.
• Create and implement subject enrollment strategies for sites.
• Ensure proper storage and accountability of Investigational Product and materials.
• Provide updates of site status to Clinical Project Manager.
• Conduct remote monitoring in line with the Monitoring Plan.
• Utilize systems to track subject status, CRF retrieval/SDV, regulatory docs, IP.

Skills

CRA experience

German language

English language

ICH-GCP knowledge

Education

Life science degree

Job description

• 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 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 (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