ph3Job Overview /h3pThe Senior Clinical Research Associate II (Sr CRA II) is responsible and accountable for site monitoring and site management for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Sr CRA II assures the implementation of project plans as assigned, functions as leader for projects of limited scope, as assigned and assumes line management responsibilities, as assigned. Acts in the project role of a Local Project Coordinator or Lead CRA as assigned. Must be based in Rome area. /ph3Summary of Responsibilities /h3ulliResponsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned. /liliEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. /liliEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. /liliMonitor data for missing or implausible data. /liliEnsure audit readiness at the site level. /liliTravel, including air travel, may be required and is an essential function of the job. /liliServe as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned. /liliConduct, report, and follow-up on Quality Control (QC) visits when requested. /liliNegotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned. /liliTrack and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. /liliAssist with training, mentoring and development of new employees, e.g., co-monitoring. /liliCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned. /li /ulh3Qualifications (Minimum Required) /h3pMandatory: University or college degree,



5 years Master's Degree in Scientific or Medical Field; CRA certification in line with Ministerial Decree of November 15, 2011. In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered. Thorough knowledge of regulatory requirements. Thorough understanding of the drug development process. Fluent in local office language and in English, both written and verbal. Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job. Fortrea may consider relevant and equivalent experience in lieu of educational requirement. /ph3Experience (Minimum Required) /h3ulli5 years minimum of Clinical Monitoring experience. /liliHave a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. /liliAdvanced site monitoring and study site management skills. /liliAdvanced registry administration skills. /liliAbility to work with minimal supervision. /liliGood planning and organization skills. /liliGood computer skills with good working knowledge of a range of computer packages Advanced verbal and written communication skills. /liliAbility to train and supervise junior staff. /liliAbility to resolve project-related problems and prioritizes workload for self and team. /liliAbility to work within a project team. /liliWorks efficiently and effectively in a matrix environment. /li /ulh3Preferred Qualifications Include /h3ulliThorough knowledge of company SOPs regarding site monitoring. /liliMinimum 1 Year experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.



/liliLocal project coordination and/or project management experience. /liliAbility to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors. /liliDemonstrated ability to conduct clinical operations activities most effectively and efficiently. /liliMethodical approach to work. /liliStrong understanding of medical and clinical research terminology, and clinical research processes. /liliAn understanding of the basics of physiology, pharmacology, and medical devices (when applicable). /liliStrong understanding of the principles of regulatory requirements. /liliGood computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications. /liliGood oral and written internal and external communication. /liliStrong interpersonal team and organizational skills, personal presentation. /liliThe ability to communicate effectively in English. /liliExperience using a clinical trial management system (CTMS). /liliFor medical device positions, experience in providing customer service to device end users. /li /ulpThe base salary range for this role is € 47,800 - 63,000 gross per year, which may vary as per working schedule (full or tempo parziale). The final offer will be determined based on objective and job-related criteria such as experience, qualifications, and scope of responsibilities, in line with our internal job classification framework and the applicable collective labour agreement (CCNL). This role may also be eligible for additional compensation, such as bonus and benefits, in accordance with company policies. /ppLearn more about our EEO Accommodations request here. /ppAt Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. /ppAt Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day. /p /p #J-18808-Ljbffr

📌 Senior Clinical Research Associate II - FSP Model - Rome Area (Milano)
🏢 FTITA Fortrea Development Limited Filiale Italiana
📍 Milano