Clinical Research Associate

JR France; La Vineuse sur Fregande; Sur place; EUR 35 000 - 50 000; Plein temps

Résumé du poste

A leading global contract research organization is seeking Clinical Research Associates (CRAs) to oversee site monitoring activities. This role involves ensuring compliance with monitoring plans, managing sites, and enhancing skills to improve project outcomes. Candidates should possess a scientific degree and relevant experience in clinical research.

Qualifications

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

Responsabilités

• Ensure adherence to the Site Monitoring Plan and quality timelines.
• Manage sites according to regulations to minimize QA audit observations.
• Assist in identifying new potential sites within therapeutic areas.

Connaissances

Communication

Multitasking

Understanding of ICH GCP

Formation

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

Description du poste

Social network you want to login/join with:

CliniRx has a number of CRA positions available.

We are expanding rapidly and have multiple permanent opportunities 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. We support clinical outsourcing needs for emerging biotech and pharmaceutical companies—most notably small to mid-size enterprises facing unique challenges. We have 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 high-quality 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.
• 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.