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Clinical Research Associate

JR Italy

Firenze

In loco

EUR 35.000 - 65.000

Tempo pieno

30+ giorni fa

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Descrizione del lavoro

An established industry player in clinical research is seeking skilled Clinical Research Associates (CRAs) to enhance their global study efforts. This role offers the opportunity to work on diverse clinical development projects, ensuring high-quality site monitoring and compliance with regulatory standards. Candidates will thrive in a collaborative environment, contributing to the identification of new sites and enhancing their skills in a rapidly expanding organization. If you are passionate about clinical research and eager to make an impact, this position is designed 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 timely and high-quality delivery of site monitoring activities.
  • Manage sites according to the Site Monitoring Master Plan and regulations.
  • Assist in identifying new potential sites across various therapeutic areas.

Conoscenze

Site Monitoring
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 this global study. Ideally, candidates will have 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, 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 key markets such as 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 high-quality delivery of site monitoring activities in accordance 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 timeliness in monitoring activities is 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 of experience in site monitoring within clinical research.
  • Skills: Strong understanding of ICH GCP and applicable clinical trial regulations; excellent verbal and written communication skills; ability to multitask and perform under demanding timelines.
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