Clinical Research Associate

JR Italy; Lucca; In loco; EUR 35.000 - 55.000; 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 in 2025. This exciting opportunity involves ensuring high-quality site monitoring activities, adhering to the Site Monitoring Plan, and contributing to the success of clinical trials. Ideal candidates will possess a strong background in clinical research, with excellent communication skills and a solid understanding of ICH GCP regulations. Join a dynamic organization that values quality and timely delivery, and be part of a team dedicated to supporting innovative healthcare solutions.

Competenze

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

Mansioni

• Deliver on the Site Monitoring Plan to ensure quality and adherence to timelines.
• Manage sites according to regulations to minimize QA audit observations.
• Assist in identifying new potential sites across various therapeutic areas.

Conoscenze

Site Monitoring

Clinical Research

Communication Skills

Time Management

Knowledge of ICH GCP

Formazione

Bachelor’s degree in a scientific discipline

Master’s degree in a scientific discipline

Descrizione del lavoro

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CliniRx CRA Positions - Global Study 2025

CliniRx has multiple CRA positions available to support a global study in Q1 2025. We are expanding rapidly and offer several permanent opportunities to join our team on this global study. Ideal candidates will have 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, including full-service CRO and functional service provider (FSP) models. We support clinical outsourcing 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.

Primary Purpose

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

Key Responsibilities

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

Work Relations

• Report to the Manager of Clinical Operations for 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 and timelines in monitoring activities is crucial for the successful delivery of our projects.

Key Success Factors

• Timely and high-quality site monitoring activities.
• Prompt report generation and stakeholder communication.
• 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 clinical trial regulations; excellent communication skills; ability to multitask under tight deadlines.