Clinical Research Associate

JR Italy; Udine; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

An established industry player is looking for skilled Clinical Research Associates (CRAs) to join their expanding team. This role involves ensuring the timely and quality delivery of site monitoring activities across various therapeutic areas. The ideal candidate will have a strong background in clinical research, excellent communication skills, and the ability to multitask effectively. You will play a vital role in supporting clinical trials for emerging biotech and pharmaceutical companies, contributing to the success of innovative projects. If you are passionate about clinical research and eager to make an impact, this opportunity is perfect for you.

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 the Site Monitoring Plan and quality standards.
• Manage sites to minimize QA audit observations.
• Assist in identifying new potential sites for clinical studies.

Conoscenze

Site Monitoring

ICH GCP Regulations

Communication Skills

Multitasking

Formazione

Bachelor’s degree in a scientific discipline

Master’s degree in a scientific discipline

Descrizione del lavoro

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

We are expanding rapidly and have 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 offer 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, with a presence in 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 line 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 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 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 understanding of ICH GCP and applicable clinical trial regulations; excellent communication skills; ability to multitask and work under demanding timelines.