Clinical Research Associate

JR France; France; Sur place; EUR 30 000 - 50 000; Plein temps

Résumé du poste

A leading contract research organization is seeking Clinical Research Associates (CRA) to ensure high-quality site monitoring across various studies. Candidates should possess a strong understanding of clinical trial regulations and have 1-4 years of relevant experience. This role promises a dynamic environment with opportunities for growth and professional development.

Qualifications

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

Responsabilités

• Deliver on the Site Monitoring Plan ensuring quality and timelines.
• Manage sites to minimize Quality Assurance audit observations.
• Assist in identifying new potential clinical 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 have a number of CRA positions available.

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

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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.
• 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.