Clinical Research Associate

JR France; Vannes; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A global contract research organization is seeking skilled Clinical Research Associates (CRAs) to ensure high-quality site monitoring activities. The role involves managing compliance, enhancing skills, and contributing to project success through timely execution of monitoring plans.

Qualifications

• 1-4 years of experience in site monitoring within clinical research.

Responsabilités

• Ensure adherence to the Site Monitoring Plan (SMP).
• Manage sites according to the SMMP and relevant regulations.
• Assist in identifying new potential sites.

Connaissances

Communication

Multitasking

Understanding of ICH GCP

Formation

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

Description du poste

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CliniRx has a number of CRA positions available.

We are expanding rapidly 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. We support clinical outsourcing needs for emerging biotech and pharmaceutical companies, especially 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.

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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:

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:

• 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.