Clinical Research Associate

JR Italy; Asti; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking skilled Clinical Research Associates to join their expanding team. This role involves ensuring the timely and quality delivery of site monitoring activities, adhering to the Site Monitoring Plan, and managing compliance with regulations. Candidates should have a solid background in clinical research, with a Bachelor's or Master's degree in a scientific discipline and experience in site monitoring. Join a dynamic organization that supports clinical outsourcing needs for biotech and pharmaceutical companies, and contribute to the success of global studies.

Competenze

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

Mansioni

• Ensure timely and quality delivery of site monitoring activities.
• Manage sites to minimize Quality Assurance audit observations.
• Assist in identifying new potential clinical sites.

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 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, reflecting both full-service CRO and functional service provider (FSP) models. We support clinical outsourcing needs for emerging biotech and pharmaceutical companies—particularly small to mid-size enterprises facing unique challenges. Our presence includes the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.

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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 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 commitment to quality and timeliness in monitoring activities is crucial for the efficient delivery of our projects and overall success.

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 applicable clinical trial regulations; excellent communication skills; ability to multitask and work under demanding timelines.