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Zusammenfassung
An established industry player in the clinical research field is seeking skilled Clinical Research Associates (CRAs) to join their rapidly expanding team. This role focuses on ensuring the timely and high-quality delivery of site monitoring activities, crucial for the success of global studies. Candidates with a solid background in clinical research and a passion for enhancing their skills will thrive in this dynamic environment. With opportunities to work on diverse projects across multiple therapeutic areas, this position offers a chance to make a significant impact in the clinical development landscape.
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 ensuring adherence to quality and timelines.
- Manage sites according to regulations to minimize QA audit observations.
- Assist in identifying new potential sites to expand the clinical network.
Kenntnisse
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CliniRx has a number of CRA positions available to support a global study in Q1 2025.
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—most notably 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.
We are seeking skilled CRAs to ensure the timely and high-quality delivery of site monitoring activities in alignment with our Site Monitoring Plan (SMP).
- 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.
- 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.
Your adherence to the quality and timelines of the monitoring plan will be crucial for the efficient delivery of our projects and overall success.
- 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.
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