Clinical Research Associate (level dependent on experience)

CTI Clinical Trial and Consulting Services; Italia; Hybrid; EUR 42,000 - 64,000; Full time

Job summary

CTI Clinical Trial and Consulting Services in Italy seeks a Clinical Research Associate to serve as main CTI contact for assigned study sites and to conduct monitoring visits in line with ICH-GCP. You will support start-up activities, manage essential regulatory documents, participate in team meetings, and help ensure accurate IP storage and trial materials.

Fluent English is required; a life science background is preferred.

Qualifications

• 3-5 years clinical research experience as a CRA
• Excellent knowledge of ICH-GCP and regulatory requirements
• Fluent English (minimum B2) in speaking and writing

Responsibilities

• Serve as main CTI contact for assigned study sites
• Conduct site visits (PSV, SIV, IMV, COV) and complete deliverables within the Monitoring Plan
• Assist with study start-up activities including feasibility and site selection
• Collect, review and track essential/regulatory documents
• Participate in general and study-specific training
• Attend investigator, client and project team meetings; may include presentations
• Create and implement subject enrollment strategies
• Ensure proper storage, dispensation and accountability of Investigational Product and trial materials
• Perform site management activities and update Clinical Project Manager
• Conduct remote monitoring per Monitoring Plan
• Use systems and reports to track subject status, CRF retrieval/SDV, regulatory documents, IP
• Assist with project-specific activities as part of the Project Team

Skills

CRA experience

Life science background

ICH-GCP knowledge

English language

Job description

** Please submit your application in English **

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
• 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.

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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