Clinical Research Associate

JR Italy; Roma; 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 dynamic team. This role focuses on delivering high-quality site monitoring activities for a global study, ensuring compliance with regulatory standards and enhancing operational efficiency. The ideal candidate will possess a strong background in clinical research, with a keen understanding of ICH GCP guidelines and excellent communication skills. Join a forward-thinking organization that values quality and timely execution, and contribute to impactful clinical projects that make a difference in healthcare.

Competenze

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

Mansioni

• Ensure adherence to quality standards and timelines in site monitoring.
• Manage sites according to the Site Monitoring Master Plan.

Conoscenze

Site Monitoring

ICH GCP

Clinical Trial Regulations

Communication Skills

Multitasking

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 Support Q1 2025

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 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 needs for emerging biotech and pharmaceutical companies, especially small to mid-size enterprises facing unique challenges. Our presence includes key markets such as the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.

Primary Purpose

We are seeking skilled CRAs to ensure the timely and 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 adherence to quality standards and timelines.
2. Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (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 enhance technical and soft skills to improve 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 is crucial for the efficient delivery and success 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 understanding of ICH GCP and clinical trial regulations; excellent communication skills; ability to multitask under demanding timelines.