Clinical Research Associate

CliniRx; Italia; In loco; EUR 35.000 - 65.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking skilled Clinical Research Associates (CRAs) to join its expanding team. This role involves ensuring the timely and qualitative delivery of site monitoring activities in alignment with the Site Monitoring Plan. The ideal candidate will have a background in clinical research, with a strong understanding of ICH GCP and the ability to thrive under demanding timelines. You will collaborate with various stakeholders to enhance project outcomes and contribute to the overall success of clinical trials. If you are passionate about advancing clinical research and making a significant 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 timelines.
• Manage sites to minimize QA audit observations and enhance performance.

Conoscenze

Site Monitoring

ICH GCP

Verbal Communication

Written Communication

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 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 areas.

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 CRAs to ensure the timely and qualitative delivery of site monitoring activities in alignment with our Site Monitoring Plan (SMP).

Key Responsibilities:

1. 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.
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 within various therapeutic areas to expand our clinical network.
4. Continuous Skill Development: Regularly enhance both technical and soft skills, applying them to elevate performance and project outcomes.

Work Relations:

1. Report to the Manager of Clinical Operations for project, functional, and administrative matters.
2. 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:

1. Timely and high-quality execution of site monitoring activities.
2. Prompt report generation and submission to stakeholders.
3. Education: Bachelor’s or Master’s degree in a scientific discipline.
4. Experience: 1-4 years of experience in site monitoring within clinical research.
5. Skills: Strong understanding of ICH GCP and applicable clinical trial regulations; excellent verbal and written communication; ability to multitask and thrive under demanding timelines.