ph3Job Overview /h3 pSite 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. /p h3Summary Of Responsibilities /h3 ul liResponsible 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. /li liResponsible for all aspects of site management as prescribed in the project plans. /li liGeneral On-Site Monitoring Responsibilities. /li liEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. /li liEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. /li liEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. /li liMonitor data for missing or implausible data. /li liEnsure 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. /li liEnsure audit readiness at the site level. /li liTravel, including air travel, may be required and is an essential function of the job. /li liPrepare accurate and timely trip reports. /li liInteract with internal work groups to evaluate needs, resources, and timelines. /li liAct as contact for clinical trial supplies and other suppliers (vendors) as assigned. /li liResponsible for all aspects of registry management as prescribed in the project plans. /li liUndertake feasibility work when requested. /li liParticipate in and follow-up on Quality Control Visits (QC) when requested.



/li liRecruitment 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. /li liTrack and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. /li liIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management. /li /ul h3Qualifications (Minimum Required) /h3 ul liMANDATORY Master's Degree (5-year university degree) in a scientific discipline, compliant with the requirements of the Italian Ministerial Decree of 15 November 2011. /li liMANDATORY CRA certification compliant with the Italian Ministerial Decree of 15 November 2011 (DM 15/11/2011). /li liMANDATORY Fluent in Italian and in English, both written and verbal and experience working with Italian sites. /li /ul h3Experience (Minimum Required) /h3 ul liMinimum 2 years of experience as independent monitor. /li liBasic understanding of Regulatory Guidelines. /li liAbility to work within a project team. /li liGood planning, organization, and problem-solving skills. /li liGood computer skills with good working knowledge of a range of computer packages. /li liWorks efficiently and effectively in a matrix environment. /li liValid Driver's License. /li /ul pThe base salary range for this role is EUR 35,000 - EUR 52,910 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 /p pLearn more about our EEO Accommodations request here. /p /p #J-18808-Ljbffr

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