Clinical Research Associate II – Senior Clinical Research

🔥 2 minutes ago

🇮🇹 Italy – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Serve as the main CTI contact for assigned study sites • Conduct pre-study, site initiation, interim monitoring, and close-out visits • Complete site visit deliverables with quality and within Monitoring Plan timelines • Assist with or oversee study start-up activities, including feasibility, pre-study activities, and site selection • Collect, review, and track essential and regulatory documents • Participate in required general and study-specific training • Participate in investigator, client, and project team meetings, including presentations • Create and implement subject enrollment strategies for assigned sites • Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials • Perform site management activities and provide ongoing site status updates to the Clinical Project Manager • Conduct remote monitoring according to the study-specific Monitoring Plan • Use systems and reports to track subject status, CRF retrieval, source document verification, regulatory documents, and investigational product • Assist with project-specific activities as a member of the Project Team

🎯 Requirements

• 3 - 5 years clinical research experience as a CRA or related profession • Life science background • Excellent knowledge in ICH-GCP and regulatory requirement • Fluent (at least Level B2) in spoken and written English • Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits • Ability to complete site visit deliverables within timelines and according to monitoring plans • Knowledge of applicable regulatory requirements, SOPs, and ICH GCP • Ability to assist with or oversee study start-up activities, feasibility, pre-study activities, and site selection • Ability to collect, review, and track essential/regulatory documents • Ability to complete general and study-specific training • Ability to create and implement subject enrollment strategies • Ability to manage investigational product and trial-related materials • Ability to conduct remote monitoring and use systems and reports to track study data • Ability to participate in investigator, client, and project team meetings, including presentations

🏖️ Benefits

• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares community and global giving opportunities • Work contributing to advancing medicine and developing life-changing treatments