SENIOR CRA FREELANCE ITALY (REMOTE) - 0.85 FTE - JUNE '26 TO JAN '27

CRA Certification and Liability Insurance in place is required

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 Senior Clinical Research Associate (SCRA) is part of Clinical Development Services (CDS) within TFS HealthScience, will function operationally as a member of a Project Team and is responsible for the initiation, on-site and/or remote monitoring and close out of study sites during study conduct, according to company policies, SOPs and 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.

· Update CTMS and all other required by projects systems with accurate site level information

· Participate in audit and/or inspection, it’s preparation and follow-up activities, as needed.

· Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.

· May assist the Clinical Research Manager or Project Manager in certain aspects of project activities

· May perform Assessment Site Visits (ASV) when requested.

· May act as mentor of CRAs.

Qualifications

· Bachelor’s Degree in life science or nursing; or equivalent

· >4-5 years of experience as CRA including relevant on-site monitoring experience, at least 1 year of experience working in OPHTHALMOLOGY studies.

· 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

· Fluent in English

· Excellent organizational skills

· Technology savvy and good software and computer skills

· Soft skills requirements: Self-awareness, resolute, flexibility, collaborative mindset, proactivity, analytic approach, and attention to detail, coach ability, motivated to take on new challenges, facilitation of discussion, diplomacy in difficult situations.

· Ability to take the ownership of the assigned tasks.

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.