Clinical Research Associate

CRA Freelance Italy 0.3 FTE

About this role

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

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

Monitor onsite 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
Initiates 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

Qualifications:

Bachelors Degree preferably in life science or nursing; or equivalent
Minimum 12 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 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

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll 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 fullservice global Contract Research Organization (CRO) we build solutiondriven 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 decisionmaking 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.