Clinical Research Associate

JR Italy; Milano; In loco; EUR 35.000 - 60.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking skilled Clinical Research Associates (CRAs) to join their expanding team for a global study. This role focuses on ensuring high-quality site monitoring activities in line with the Site Monitoring Plan. Ideal candidates will have a scientific background and experience in clinical research, with a strong understanding of ICH GCP standards. Join a dynamic organization that values quality and timely execution, contributing to the success of clinical trials across various therapeutic areas. If you're ready to enhance your skills and make an impact, this opportunity is for you.

Competenze

• 1-4 years of experience in site monitoring within clinical research.
• Strong knowledge of ICH GCP and clinical trial regulations.

Mansioni

• Ensure timely and high-quality delivery of site monitoring activities.
• Manage sites to minimize Quality Assurance audit observations.
• Assist in identifying new potential sites across therapeutic areas.

Conoscenze

Site Monitoring

ICH GCP

Verbal Communication

Written Communication

Multitasking

Formazione

Bachelor's Degree in a Scientific Discipline

Master's Degree in a Scientific Discipline

Descrizione del lavoro

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CliniRx has a number of CRA positions available to support a global study in Q1 2025.

We are expanding rapidly and offer multiple permanent opportunities to join us on a global study. Ideally, candidates will come from a CRO background with experience across multiple therapeutic areas.

As a global contract research organization (CRO), we provide a diverse range of clinical development and resource solutions, reflecting both full-service CRO and functional service provider (FSP) models. We support clinical outsourcing needs for emerging biotech and pharmaceutical companies, especially small to mid-size enterprises facing unique challenges. Our presence includes the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.

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Primary Purpose:

We are seeking skilled CRAs to ensure the timely and high-quality delivery of site monitoring activities in line with our Site Monitoring Plan (SMP).

Key Responsibilities:

• Deliver on the Site Monitoring Plan: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality standards and timelines.
• Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (QA) audit observations.
• Site Identification: Assist in identifying new potential sites across various therapeutic areas to expand our clinical network.
• Continuous Skill Development: Regularly improve technical and soft skills to enhance performance and project outcomes.

Work Relations:

• Report to the Manager of Clinical Operations regarding project, functional, and administrative matters.
• Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative staff.

Value Added:

Your adherence to quality standards and timelines in monitoring activities is crucial for the successful delivery of our projects.

Key Success Factors:

• Timely and high-quality execution of site monitoring activities.
• Prompt report generation and submission to stakeholders.
• Education: Bachelor’s or Master’s degree in a scientific discipline.
• Experience: 1-4 years in site monitoring within clinical research.
• Skills: Strong knowledge of ICH GCP and applicable clinical trial regulations; excellent verbal and written communication skills; ability to multitask and perform under demanding deadlines.