ph3Job Overview /h3pSite monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. /ph3Job Overview /h3pSite monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. /ph3Summary Of Responsibilities /h3ulliResponsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned. /liliResponsible for all aspects of site management as prescribed in the project plans. /liliGeneral On-Site Monitoring Responsibilities. /liliEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. /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 the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines,



including managing travel expenses in an economical fashion according to Fortrea travel policy. /liliEnsure audit readiness at the site level. /liliTravel, including air travel, may be required and is an essential function of the job. /liliPrepare accurate and timely trip reports. /liliInteract with internal work groups to evaluate needs, resources, and timelines. /liliAct as contact for clinical trial supplies and other suppliers (vendors) as assigned. /liliResponsible for all aspects of registry management as prescribed in the project plans. /liliUndertake feasibility work when requested. /liliParticipate in and follow-up on Quality Control Visits (QC) when requested. /liliRecruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 18) Assist Senior CRA with managing investigator site budgets. /liliTrack and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.



/liliIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management. /li /ulh3Qualifications (Minimum Required) /h3ulliMANDATORY Master's Degree (5-year university degree) in a scientific discipline, compliant with the requirements of the Italian Ministerial Decree of 15 November 2011 /liliMANDATORY CRA certification compliant with the Italian Ministerial Decree of 15 November 2011 (DM 15/11/2011). /liliMANDATORY Fluent in Italian and in English, both written and verbal. /li /ulh3Experience (Minimum Required) /h3ulliMinimum 1 year of experience as independent monitor. /liliBasic understanding of Regulatory Guidelines. /liliAbility to work within a project team. /liliGood planning, organization, and problem-solving skills. /liliGood computer skills with good working knowledge of a range of computer packages. /liliWorks efficiently and effectively in a matrix environment. /liliValid Driver's License. /li /ulpThe base salary range for this role is EUR 32.200 - EUR 48.840 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. /p /p #J-18808-Ljbffr

📌 Clinical Research Associate I - Full Service Operations Model - Italy (Milano)
🏢 Fortrea
📍 Milano