Clinical Research Associate

2 mesi fa

Lazio, Italia Indiana Biosciences Research Institute 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 ResourcingSolutions Unit within TFS Develop and will function operationally as a member of a Project Team andis responsible for the initiation, on–site and remote monitoring and termination of investigative sitesduring study conduct, according to company policies, SOPs and regulatory requirements.
The CRA may conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, andclose-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 companyStandard Operating Procedures, FDA regulations, and GCP and ICH guidelines
Review CRFs (paper or electronic) and subject source documentation for validity andaccuracy and generate queries to investigational sites/clients to resolve problem data
Identify site problems/deficiencies and bring to the attention of management through tripreporting, memos, and verbal communication with Project Manager or Lead CRA
Initiates corrective action to resolve issues as directed by supervisor
Contribute to the completion of the application to Ethics Committee/IRB, prepare necessarydocumentation enclosed to the application according to local requirements in cooperationwith 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 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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