Clinical Research Associate

JR Italy; Padova; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking skilled Clinical Research Associates (CRAs) to join their team for a global study. This role focuses on ensuring the timely and qualitative delivery of site monitoring activities, adhering to the Site Monitoring Plan. Candidates should possess a strong understanding of ICH GCP and clinical trial regulations, along with excellent communication skills. With opportunities for continuous skill development, this position offers a chance to contribute significantly to the success of clinical projects while working collaboratively in a dynamic environment.

Competenze

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

Mansioni

• Ensure timely and qualitative delivery of site monitoring activities.
• Manage sites according to the Site Monitoring Master Plan and regulations.
• Assist in identifying new potential sites within various therapeutic areas.

Conoscenze

Site Monitoring

ICH GCP

Clinical Trial Regulations

Communication Skills

Multitasking

Formazione

Bachelor's Degree in a Scientific Discipline

Master's Degree in a Scientific Discipline

Descrizione del lavoro

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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 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

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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.
• 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.