Clinical Research Associate

2 mesi fa

Roma, Italia TFS HealthScience A tempo pieno

**CRA Italy - 0.2/0.4 FTE - FREELANCE**

**About this role**

TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions

The Clinical Research Associate (CRA) is part of Clinical Operations or Strategic Resourcing Solutions Unit within TFS Develop and will function operationally as a member of a Project Team and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements.
The CRA may conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Ability to travel as needed: may involve overnight and international travel.
- As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in medical devices_

**Key Responsibilities (Max 5-6)**
- Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines

**Qualifications: (Max 5-6)**

Bachelor’s Degree, preferably in life science or nursing; or equivalent
Minimum 1-3 years of relevant clinical experience
- Former experience in Medical Devices and ideally good knowledge in Cardiovascular therapeutic area
- Able to work in a fast paced environment with changing priorities
Understand basic medical terminology and science associated with the assigned drugs and
therapeutic areas
Possess the understanding of Good Clinical Practice regulations, ICH guidelines
Ability to work independently as well as in a team matrix organization
Excellent written and verbal communication skills.
Excellent organizational skills
Ability and willingness to travel up to 60-70%

**What We Offer**

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

**A Bit More About Us**

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. **Together we make a difference.

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