Clinical Research Associate

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

Descrizione del lavoro

An innovative contract research organization is on the lookout for skilled Clinical Research Associates (CRAs) to join their rapidly expanding team. This role is pivotal in ensuring the timely and high-quality delivery of site monitoring activities for a global study. With a focus on quality standards and compliance, you will work closely with site personnel and the clinical operations team. This opportunity offers a dynamic work environment where your contributions will significantly impact clinical development projects. If you have a background in clinical research and are ready to take the next step in your career, this position 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

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

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 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 diverse 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 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 adherence to quality 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 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 standards and timelines will be crucial for the efficient delivery of our projects and overall success.

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 and work under demanding timelines.