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Clinical Research Associate

CliniRx

Firenze

In loco

EUR 30.000 - 45.000

Tempo pieno

29 giorni fa

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Descrizione del lavoro

CliniRx seeks Clinical Research Associates (CRAs) to support a global study, ensuring timely and qualitative site monitoring. Candidates should have a background in clinical research, ideally from a CRO, with solid understanding of ICH GCP and relevant regulations.

Competenze

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

Mansioni

  • Deliver on the Site Monitoring Plan ensuring adherence to quality and timelines.
  • Assist in identifying new potential sites to expand the clinical network.
  • Manage sites according to the SMMP and relevant regulations.

Conoscenze

Communication
Multitasking
Understanding of ICH GCP

Formazione

Bachelor’s or Master’s degree in a scientific discipline

Descrizione del lavoro

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

We are expanding at a rapid rate and have multiple opportunities on a permanent basis to join us on a global study. Ideally you will come from a CRO background with experience across multiple therapeutic area's.

As a global contract research organization (CRO), we offer a diverse slate of clinical development and resource solutions reflecting both full-service CRO and functional service provider (FSP) models. In supporting clinical outsourcing needs for emerging biotech and pharmaceutical companies—most notably small to mid-size enterprises facing unique challenges we offer our expertise with a presence in key markets including the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia

Primary Purpose : We are seeking skilled CRA's to ensure the timely and qualitative delivery of site monitoring activities in alignment with our Site Monitoring Plan (SMP).

Key Responsibilities :

  • Deliver on the Site Monitoring Plan : Gain a comprehensive understanding of the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality 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 within various therapeutic areas to expand our clinical network.
  • Continuous Skill Development : Regularly enhance both technical and soft skills, applying them to elevate 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 executives.

Value Added :

Your adherence to the quality and timelines of the monitoring plan 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.

Essential Skills Experience :

  • 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; ability to multitask and thrive under demanding timelines.
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