Senior Clinical Research Associate II - FSP Model - Italy

ppbJob Overview: /b /p pThe 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. /p pbMust be based in well connected cities, preferably center North Italy. /b /p pbSummary of Responsibilities: /b /p ul lipThe statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties. /p /li lipResponsible 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. /p /li lipEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. /p /li lipEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. /p /li lipMonitor data for missing or implausible data. /p /li lipEnsure audit readiness at the site level. /p /li lipTravel, including air travel, may be required and is an essential function of the job. /p /li lipServe as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned. /p /li lipConduct, report, and follow-up on Quality Control (QC) visits when requested. /p /li lipNegotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned. /p /li lipTrack and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. /p /li lipAssist with training, mentoring and development of new employees, e.g., co-monitoring. /p /li lipCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned. /p /li /ul pbQualifications (Minimum Required): /b /p ul lipMandatory: 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. /p /li lipIn lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered. /p /li lipThorough knowledge of regulatory requirements. /p /li lipThorough understanding of the drug development process. /p /li lipFluent in local office language and in English, both written and verbal. /p /li lipOr an equivalent combination of education and experience to successfully perform the key responsibilities of the job. /p /li lipFortrea may consider relevant and equivalent experience in lieu of educational requirement. /p /li /ul pbExperience (Minimum Required): /b /p ul lip5 years minimum of Clinical Monitoring experience. /p /li lipHave a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. /p /li lipAdvanced site monitoring and study site management skills. /p /li lipAdvanced registry administration skills. /p /li lipAbility to work with minimal supervision. /p /li lipGood planning and organization skills. /p /li lipGood computer skills with good working knowledge of a range of computer packages /p /li lipAdvanced verbal and written communication skills. /p /li lipAbility to train and supervise junior staff. /p /li lipAbility to resolve project-related problems and prioritizes workload for self and team. /p /li lipAbility to work within a project team. /p /li lipWorks efficiently and effectively in a matrix environment. /p /li /ul pbPreferred Qualifications Include: /b /p ul lipThorough knowledge of company SOPs regarding site monitoring. /p /li lipMinimum 1 Year experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. /p /li lipLocal project coordination and/or project management experience. /p /li lipAbility to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors. /p /li lipDemonstrated ability to conduct clinical operations activities most effectively and efficiently. /p /li lipMethodical approach to work. /p /li lipStrong understanding of medical and clinical research terminology, and clinical research processes. /p /li lipAn understanding of the basics of physiology, pharmacology, and medical devices (when applicable). /p /li lipStrong understanding of the principles of regulatory requirements. /p /li lipGood computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications. /p /li lipGood oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English. /p /li lipExperience using a clinical trial management system (CTMS). /p /li lipFor medical device positions, experience in providing customer service to device end users. /p /li /ul pThe base salary range for this role is € 47,800 - 63,000 gross per year, which may vary as per working schedule (full or part-time). 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. /p pLearn more about our EEO Accommodations request here. /p /p #J-18808-Ljbffr