Clinical Research Associate

JR Italy; Lecce; In loco; EUR 35.000 - 65.000; Tempo pieno

Descrizione del lavoro

An established industry player in clinical research is seeking skilled Clinical Research Associates (CRAs) to join their team. This role focuses on ensuring the timely and high-quality delivery of site monitoring activities. You will gain a comprehensive understanding of the Site Monitoring Master Plan and collaborate with diverse teams to enhance project outcomes. With a commitment to quality and efficiency, this position offers a unique opportunity to contribute to global studies while developing your professional skills in a dynamic environment. If you have a CRO background and are passionate about making a difference, this is the perfect opportunity for you.

Competenze

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

Mansioni

• Ensure adherence to the Site Monitoring Plan for quality and timelines.
• Manage sites according to regulations to minimize audit observations.

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 have a CRO background with experience across multiple therapeutic areas.

As a global contract research organization (CRO), we offer diverse 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—particularly small to mid-size enterprises facing unique challenges—with 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 alignment with our Site Monitoring Plan (SMP).

Key Responsibilities:

1. 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.
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 enhance both technical and soft skills, applying them to improve performance and project outcomes.

Work Relations:

1. Report to the Manager of Clinical Operations for project, functional, and administrative matters.
2. 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:

1. Timely and high-quality execution of site monitoring activities.
2. Prompt report generation and submission to stakeholders.
3. Education: Bachelor’s or Master’s degree in a scientific discipline.
4. Experience: 1-4 years of experience in site monitoring within clinical research.
5. Skills: Strong understanding of ICH GCP and applicable clinical trial regulations; excellent verbal and written communication; ability to multitask and thrive under demanding timelines.