Clinical Research Associate

JR Italy; Bolzano; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is expanding its operations and seeking skilled Clinical Research Associates (CRAs) to join their dynamic team. This role focuses on ensuring high-quality site monitoring activities in line with the Site Monitoring Plan. Candidates should have a strong background in clinical research, particularly within a CRO environment, and be adept at managing multiple therapeutic areas. The company prides itself on delivering exceptional clinical development solutions and offers a collaborative environment where your contributions directly impact project success. If you're passionate about advancing clinical trials and thrive in a fast-paced setting, this opportunity is perfect for you.

Competenze

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

Mansioni

• Ensure adherence to the Site Monitoring Plan and quality standards.
• Manage sites to minimize Quality Assurance audit observations.
• Assist in identifying new potential sites for clinical trials.

Conoscenze

Site Monitoring

ICH GCP

Communication Skills

Multitasking

Formazione

Bachelor's Degree in a Scientific Discipline

Master's Degree in a Scientific Discipline

Descrizione del lavoro

Social network you want to login/join with:

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. We have a presence in key markets including 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 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 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 in monitoring activities is crucial for the efficient delivery and success of our projects.

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 skills; ability to multitask and work effectively under demanding timelines.