pProvide support to Clinical Affairs team to assure study site selection and conduct of the study by study sites in compliance with Good Clinical Practices, federal regulations, and Clinical Affairs SOPs through in-house and some on-site monitoring /pulliConduct pre-study visits to assure the site has adequate facilities, staff, and subject population for conducting the study within established time frames /liliCoordinate the distribution of supplies to study sites and assure an adequate quantity of supplies on hand during the course of the study /liliTrack distribution and return of all study materials and drug /liliConduct site initiation in order to ensure that all elements are in place for performing the study according to protocol and in compliance with all applicable regulations and good clinical practice guidelines /liliPerform interim site monitoring visits and document findings in a monitoring report which will be completed in a timely manner /liliPerform close-out visits to all study sites /liliAssist in maintenance of Trial Master Files (TMFs) /liliAssist with preparation of informed consent (ICFs), case report forms (CRFs),



study support documents for assigned studies /liliReview site generated ICFs for compliance with study protocol and federal regulations /liliReview and provide feedback to Clinical Trial Team Lead on data management documents /liliReview and provide feedback to Clinical Trial Team on pharmacovigilance plans for assigned studies /liliEvaluate and recommend selection of investigators/study sites /liliTrain investigators, coordinator, and other trial staff in data collection methods to ensure collection of patient data that is accurate, complete, and conforms to project data standards and protocol requirements /liliEnsure the collection, review, and updating of all essential documents defined by FDA regulations, company industry standards /li /ulh3Job Experience: /h3ulli2+ years of relevant working experience in a clinical research setting at a CRO /liliOr an R.N. or Bachelor's degree in biological sciences or other healthcare related field with/without related clinical research experience /liliWorking knowledge of the FDA CFRs and Good Clinical Practice Guidelines associated with CRA activities /liliMust be proactive and able to work independently and with teams /liliExcellent written and verbal communication skills /liliLiteracy in Microsoft Office (Word, Outlook, and Excel) /liliAbility and willingness to travel possibly up to 50% of the time /li /ulpOxford is an Equal Opportunity Employer. All applicants will receive consideration for employment without regard to race, ethnic origin, religion, sex, age, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by law. All persons hired will be required to verify identity and eligibility to work in the Country in which they have applied to work. /p #J-18808-Ljbffr

📌 Clinical Research Associate (Italia)
🏢 Oxford Global Resources
📍 Italia