Requirements: English
Company: CliniRx
Region: Latina , Lazio
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 companiesmost 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
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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: Bachelors or Masters 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.