Clinical Research Associate (level dependent on experience)

CTI Clinical Trial and Consulting Services; France; Hybride; EUR 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Hybrid work opportunities

CTI Cares program

Résumé du poste

CTI Clinical Trial and Consulting Services is seeking a Clinical Research Professional to manage assigned study sites and oversee monitoring activities. You will conduct site visits (PSV, SIV, IMV, COV) and ensure quality deliverables within timelines, while adhering to regulatory requirements and ICH-GCP.

The role requires 3–5 years of clinical research experience as a CRA or related field with experience in Germany; strong life science background and fluent English (B2).

Qualifications

• Life science background.
• Excellent knowledge in ICH-GCP and regulatory requirement.
• Fluent in English (B2) in spoken and written form.

Responsabilités

• Serve as main CTI contact for assigned study sites.
• Conduct site visits (PSV, SIV, IMV, COV) and complete site visit deliverables per Monitoring Plan.
• Assist with or oversee study start-up activities, including feasibility and site selection.
• Collect, review and track essential/regulatory documents.
• Complete general and study-specific trainings as required.
• Attend 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 Investigational Product and trial materials.

Connaissances

Life science

ICH-GCP

English B2

Description du poste

• 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.