Clinical Research Associate

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

Zusammenfassung

CliniRx is expanding and seeking skilled Clinical Research Associates (CRAs) to join their team. The role involves ensuring high-quality site monitoring activities, adhering to timelines, and managing site compliance. Ideal candidates have a scientific 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 and ensure quality adherence.
• Manage sites to minimize Quality Assurance audit observations.
• Assist in identifying new potential sites.

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 :

1. Deliver on the Site Monitoring Plan: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure quality and adherence to 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 improve technical and soft skills to enhance performance and project outcomes.

Work Relations :

• Report to the Manager of Clinical Operations regarding 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, 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.