Clinical Research Associate

CliniRx; Leipzig; Vor Ort; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

CliniRx is expanding and seeking Clinical Research Associates (CRA) in Leipzig. The role involves site monitoring and ensuring compliance with clinical trial regulations. Ideal candidates will have a scientific background and experience in clinical research.

Qualifikationen

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

Aufgaben

• Deliver on the Site Monitoring Plan and ensure adherence to quality.
• Manage sites according to the SMMP and relevant regulations.
• Assist in identifying new potential sites within various therapeutic areas.

Kenntnisse

Communication

Multitasking

Ausbildung

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

Jobbeschreibung

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

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.

Clinical Research Associate • Leipzig, DE