CRA / SENIOR CRA - Homebased (Italy) Temporary (1 year
with possibility to be extended) 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. Join Our Team as a Clinical Research Associate
home-based in Italy About This Role The Clinical Research Associate
(CRA) is part of Strategic Resourcing Solutions (SRS) within TFS
Health Science and will function operationally as a member of a
Project Team and is responsible for the initiation, on–site and/or
remote monitoring, close out of study sites during study conduct,
according to company policies, SOPs and GCP and ICH guidelines and
other regulatory requirements. Key Responsibilities · Monitor
on-site and remotely clinical trials in accordance with TFS and/or
sponsor Standard Operating Procedures GCP and ICH guidelines and
applicable regulatory regulations. Perform all required monitoring
activities at the study sites to assess and ensure subjects safety,
data integrity and quality. · Verify the protection of study
participants by informed consent procedures and protocol
requirements that follow appropriate regulations. · Review CRFs
(electronic or paper) and subject source documentation for validity
and accuracy · Verify proper management and accountability of
Investigational Product. · Timely reporting of actions taken during
monitoring visits in Monitoring Visit Report including findings,
corrective and preventive actions already taken and update
applicable tracking systems, as required; escalate observed
deficiencies and issues as appropriate. · Providing site with the




listing of issues identified during monitoring visit and action
items which will need to be addressed in a timely manner. · Timely
delivering site documents to eTMF or paper TMF; verify that the
Investigator's Site File (ISF) is maintained in accordance with GCP
and ICH guidelines and local regulatory requirements. · Participate
in audit and/or inspection, its preparation and follow-up
activities, as needed. · Order, ship, and reconcile clinical
investigative supplies for study sites, if applicable · Update CTMS
and all other required by projects systems with accurate site level
information Qualifications Bachelor’s Degree, preferably in life
science or nursing; or equivalent · At least 3 years of experience
monitoring clinical trials in Oncology, including at least one
involved in early-phase studies (Phase I or II). · 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. · Strong
written and verbal communication skills. · Fluent in English ·
Excellent organizational skills · Technology savvy and good
software and computer skills · Soft skills: Self-awareness,
resolute, flexibility, proactivity, collaborative mindset, analytic




approach, and attention to detail · Ability and willingness to
travel up to 60-80%, overnight and abroad if applicable. 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 Salary: 42.000-58.000 gross/year (depending on the level
of experience), in line with CCNL Terziario-Servizi (Level III),
plus benefits (lunch vouchers, health insurance, pension, and car
allowance where applicable 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.

📌 (Senior) Clinical Research Associate (Lazio)
🏢 Tfs Healthscience
📍 Lazio