Clinical Research Associate II – Senior Clinical Research

🕒 April 29

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

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 primary 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 to a high standard and within the timelines defined in the Monitoring Plan, while adhering to all applicable regulatory requirements, SOPs, and ICH-GCP • Assist with or oversee study start-up activities, including feasibility assessments, pre-study activities, and site selection • Collect, review and track essential and regulatory documents • Participate in and complete all general and study-specific training as required • Attend investigator, client, and project team meetings; may include giving presentations • Develop and implement subject enrollment strategies for assigned study sites • Ensure appropriate storage, dispensing, and accountability of all Investigational Product (IP) and trial-related materials • Perform site management activities and provide ongoing updates on site status to the Clinical Project Manager • Conduct remote monitoring and complete related activities in accordance with the study-specific Monitoring Plan • Use systems and reports to track subject status, CRF retrieval / source document verification (SDV), regulatory documents, and IP • Support project-specific activities as a member of the Project Team

🎯 Requirements

• 3–5 years of clinical research experience as a CRA or in a related role in Germany, including independent monitoring experience within Germany • Degree or background in life sciences • Strong knowledge of ICH-GCP and regulatory requirements • Fluent in German and English (spoken and written), minimum CEFR level B2

🏖️ Benefits

• Health insurance • Professional development opportunities • Hybrid work options