pTFS 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 Freelance Senior Clinical Research Associate (0.4 FTE) - home based in Italy. /ph3About this role /h3pAs part of our Ophthalmology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Freelance Senior Clinical Research Associate 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. The Freelance Senior Clinical Research Associate will provide Unmasked Clinical Research Associate support for assigned clinical studies, including management of investigational product accountability, oversight of unblinded site activities, and monitoring of protocol compliance in accordance with study requirements and applicable regulations. The Freelance Senior Clinical Research Associate will collaborate with study teams, investigative sites and sponsors to ensure timely execution of study deliverables while maintaining the integrity of study blinding and data quality. /ph3Key Responsibilities: /h3ulliMonitor 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. /liliVerify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations. /liliReview CRFs (electronic or paper)



and subject source documentation for validity and accuracy /liliVerify proper management and accountability of Investigational Product /liliTimely 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; escalat observed deficiencies and issues as appropriate. /liliProviding site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner. /liliTimely delivering site documents to eTMF or paper TMF. /liliVerify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements. /liliUpdate CTMS and all other required by projects systems with accurate site level information /liliParticipate in audit and/or inspection, it’s preparation and follow-up activities, as needed. /liliOrder, ship, and reconcile clinical investigative supplies for study sites, if applicable. /liliMay assist the Clinical Research Manager or Project Manager in certain aspects of project activities which may include:ulliproject tracking, /lilimonitoring plans, /liliReview of monitoring reports /liliCRA resources management within the project /li /ul /liliMay perform Assessment Site Visits (ASV) when requested. /liliMay act as a mentor to CRAs. /liliMay develop and implement therapeutic area training for other CRAs and project team members. /liliMay participate in capabilities presentations. /li /ulh3Qualifications: /h3ulliBachelor’s Degree, preferably in life science or nursing; or equivalent /lili5 years of independent on-site monitoring experience and at least 1 year experience as an unmasked monitor is required. /liliAt least 1 year Ophthalmology, ideally within a retina indication (i.e. Age-related Macular Degeneration, Diabetic Macular Edema, Geographic Atrophy, RVO, BRVO, CRVO,



etc.), experience is preferred. /liliAble to work in a fast-paced environment with changing priorities. /liliUnderstand basic medical terminology and science associated with the assigned drugs and therapeutic areas. /liliPossess the understanding of Good Clinical Practice regulations, ICH guidelines. /liliAbility to work independently as well as in a team matrix organization. /liliExcellent written and verbal communication skills /liliFluent in English and local language /liliExcellent organizational skills /liliTechnology savvy and good software and computer skills /liliSoft 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. /liliAbility to take the ownership of the assigned tasks. /liliAbility to manage complex or early phases studies. /liliAbility and willingness to travel up to 60-80%, overnight and abroad, if applicable. /li /ulh3What We Offer /h3ulliWe provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. /liliYou’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients /li /ulpWe welcome applications from candidates belonging to protected categories under art. 1 L. 68/99. /ph3A Bit More About Us /h3pOur journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. /ppWe currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East. /ppOur core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. /p #J-18808-Ljbffr

📌 Freelance Senior Clinical Research Associate (Italia)
🏢 Tfs Healthscience
📍 Italia