16 ott - Italia
Thermofisher Scientific
h3Work Schedule /h3pStandard (Mon-Fri) /ph3Environmental Conditions /h3pOffice /ph3Job Description /h3pWe're looking for a bClinical Research Associate II (CRA II) /b to join our growing Clinical Operations team in bItaly /b. If you're passionate about clinical research, enjoy building strong site relationships, and want to contribute to studies that make a real difference for patients worldwide, we'd love to hear from you. /ph3What You'll Do /h3pAs a CRA II, you'll be responsible for monitoring clinical trial sites and ensuring studies are conducted in compliance with protocols, ICH-GCP guidelines, applicable regulations, and company SOPs. /ppYour responsibilities will include: /pulliConducting on-site and remote monitoring visits using a Risk-Based Monitoring (RBM) approach. /liliEnsuring subject safety, data integrity, and protocol compliance. /liliPerforming Source Data Verification (SDV), Source Data Review (SDR), and CRF review. /liliAssessing investigational product accountability through inventory and documentation reviews. /liliIdentifying site issues, performing root cause analysis, and implementing corrective and preventive actions (CAPA). /liliPreparing high-quality monitoring reports and ensuring timely follow-up of action items. /liliSupporting site initiation, routine monitoring, and close-out visits. /liliReviewing essential documents to ensure compliance with ICH-GCP and regulatory requirements. /liliMaintaining study documentation and updating clinical trial management systems (CTMS). /liliBuilding collaborative relationships with investigators, site staff, sponsors,
and cross-functional project teams. /liliSupporting audit and inspection readiness throughout the study lifecycle. /liliParticipating in investigator meetings and contributing to process improvement initiatives. /liliCompleting administrative activities, including expense reports and timesheets, accurately and on time. /li /ulh3What We're Looking For /h3h3Required Qualifications /h3ulliMaster's degree in Life Sciences or an equivalent scientific qualification. /liliApproximately b1+ year of clinical monitoring experience /b as a Clinical Research Associate or equivalent. /liliGood knowledge of ICH-GCP guidelines and applicable clinical research regulations. /liliValid driver's license. /liliFluency in bItalian and English /b, both written and spoken. /li /ulh3Skills Competencies /h3pWe're looking for someone who brings: /pulliStrong clinical monitoring experience. /liliSolid understanding of clinical trial processes and medical terminology. /liliKnowledge of Risk-Based Monitoring principles. /liliExcellent analytical thinking and problem-solving skills. /liliAbility to identify root causes and proactively resolve issues. /liliStrong communication and relationship-building skills.
/liliHigh attention to detail and commitment to quality. /liliExcellent planning, organization, and time management abilities. /liliCustomer-focused mindset with the ability to collaborate across diverse teams. /liliFlexibility and adaptability in a dynamic environment. /liliProficiency in Microsoft Office and clinical systems. /li /ulh3Working Environment /h3pThis role offers flexibility with a combination of home office, office, and clinical site-based work. /ppThe position requires: /pulliFrequent travel to investigator sites across Italy. /liliRegular driving. /liliOccasional overnight stays. /li /ulh3Why Join Thermo Fisher Scientific? /h3pWhen you join us, you'll become part of a global organization dedicated to enabling our customers to make the world healthier, cleaner, and safer. /ph3We offer: /h3ulliThe opportunity to work on innovative global clinical trials. /liliA collaborative and supportive international environment. /liliOngoing professional development and career growth. /liliExposure to leading pharmaceutical and biotechnology sponsors. /liliA culture that values inclusion, innovation, and excellence. /li /ulpIf you're ready to advance your CRA career while contributing to research that changes patients' lives, we'd love to hear from you. /ppThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p #J-18808-Ljbffr
17 ott - Piove di sacco
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17 ott - Roma
elettroteammarrinisrls
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OPENJOBMETIS