Clinical Research Associate

CliniRx; Düsseldorf; Vor Ort; EUR 45.000 - 70.000; Vollzeit

Zusammenfassung

An established industry player is seeking skilled Clinical Research Associates (CRAs) to join their expanding team. This role focuses on ensuring the timely and qualitative delivery of site monitoring activities aligned with the Site Monitoring Plan. The ideal candidate will have a background in clinical research, particularly within a CRO environment, and possess strong skills in ICH GCP and site management. This position offers a unique opportunity to contribute to global studies and develop professionally in a dynamic and supportive environment.

Qualifikationen

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

Aufgaben

• Deliver on the Site Monitoring Plan and ensure adherence to quality.
• Manage sites according to regulations to minimize QA audit observations.

Kenntnisse

Site Monitoring

ICH GCP

Communication Skills

Multitasking

Ausbildung

Bachelor's degree in a scientific discipline

Master's degree in a scientific discipline

Jobbeschreibung

CliniRx have 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 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

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.

Essential Skills Experience :

• 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.