Clinical Research Associate

CLINICAL RESEARCH ASSOCIATE - BASED IN ROME - HYBRID (3 days working at the office)

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 Development Services (CDS) or 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

· Over 2 years of experience working as a CRA (with CRA certification)

· 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

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.