Clinical Research Associate

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

Descrizione del lavoro

An established industry player is seeking skilled Clinical Research Associates (CRAs) to join their dynamic team. This role is crucial for ensuring the timely and high-quality delivery of site monitoring activities for global studies. Ideal candidates will have a background in clinical research and a strong understanding of ICH GCP and clinical trial regulations. You will be part of a collaborative environment, working closely with site personnel and the clinical operations team. If you are passionate about advancing clinical research and thrive in a fast-paced setting, 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

• Deliver on the Site Monitoring Plan ensuring adherence to quality standards.
• Manage sites to minimize Quality Assurance audit observations.
• Identify new potential sites to expand clinical network.

Conoscenze

Site Monitoring

ICH GCP

Clinical Trial Regulations

Verbal Communication

Written Communication

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 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—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 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:

1. Report to the Manager of Clinical Operations regarding project, functional, and administrative matters.
2. Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative staff.

Value Added:

Your adherence to quality standards and timelines in monitoring activities is crucial for the successful delivery of our projects.

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 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 work under demanding timelines.