Elettronica jobs in United States

CRA Freelance - Italy - 0.2 - 0.3 FTE

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.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global leader in implantable hearing solutions.

• 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.
• Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data.
• Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA.
• Initiate corrective action to resolve issues as directed by supervisor.
• Contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager.
• Participate in contract handling and negotiation directed by Lead CRA/Project Manager.
• Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites. In cooperation with study team, responsible for SMF maintenance.
• Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
• Order, ship and coordination of study supplies at site.
• May prepare and submit status reports as directed by Lead CRA/PM.
• Review and support site staff to maintain SMF.
• Review Informed Consent documents for essential elements and protocol specifics.
• Update CTMS system with site and study information.
• May audit data in tables and text of clinical summaries.
• May assist in the preparation of study documentation such as CRF Completion Guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness.
• Prepare check requisitions for sponsor Project Manager approval, when applicable.

• Bachelor’s Degree, preferably in life science or nursing; or equivalent.
• Minimum 1-2 years of experience working as a CRA (with experience in medical devices would be a plus).
• 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.

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.

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.