Clinical Research Associate

JR Italy; Lodi; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking skilled Clinical Research Associates (CRAs) to join their expanding team. This exciting opportunity involves ensuring high-quality site monitoring activities for a global study. Candidates will be part of a dynamic environment, contributing to the success of clinical trials across various therapeutic areas. The role emphasizes the importance of quality, adherence to timelines, and continuous skill development. Ideal candidates will bring a solid background in clinical research and a commitment to excellence, making a significant impact on project outcomes.

Competenze

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

Mansioni

• Deliver on the Site Monitoring Plan to ensure quality standards.
• Manage sites to minimize Quality Assurance audit observations.
• Assist in identifying new potential sites across therapeutic areas.

Conoscenze

Site Monitoring

Clinical Research

ICH GCP

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 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 various 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 spans key markets including 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 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 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 commitment to quality and adherence to timelines is crucial for the successful delivery of our projects.

Key Success Factors:

• Timely, 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 and work under demanding timelines.