Clinical Research Associate

CliniRx; Essen; Vor Ort; EUR 50.000 - 65.000; Vollzeit

Zusammenfassung

CliniRx is seeking skilled Clinical Research Associates (CRAs) to ensure high-quality site monitoring activities. The role involves managing compliance, site identification, and continuous skill development, crucial for project success. Ideal candidates have a CRO background and experience in clinical research.

Qualifikationen

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

Aufgaben

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

Kenntnisse

Communication

Multitasking

Ausbildung

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

Jobbeschreibung

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, candidates will come from a CRO background with experience across multiple therapeutic areas.

As a global contract research organization (CRO), we offer a diverse range 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. Our presence includes key markets such as 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 line with our Site Monitoring Plan (SMP).

Key Responsibilities:

• Deliver on the Site Monitoring Plan: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality standards and timelines.
• Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize QA audit observations.
• Site Identification: Assist in identifying new potential sites across various therapeutic areas to expand our clinical network.
• Continuous Skill Development: Regularly enhance technical and soft skills to improve 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 staff.

Value Added:

Your adherence to quality standards and timelines is 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 and Experience:

• Education: Bachelor’s or Master’s degree in a scientific discipline.
• Experience: 1-4 years in site monitoring within clinical research.
• Skills: Strong understanding of ICH GCP and applicable clinical trial regulations; excellent verbal and written communication skills; ability to multitask and work under demanding timelines.