Clinical Trial Coordinator (Bologna)

Clinical Trial Coordinator (Bologna)

15 ago
|
Thermofisher Scientific
|
Bologna

15 ago

Thermofisher Scientific

Bologna

ph3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 h3Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation /h3 h3What You'll Do /h3 h3Clinical Trial Documentation Support /h3 ul lipCoordinate and complete assigned clinical trial activities in accordance with the study task matrix.
/p /li lipPerform Country and Investigator file reviews and document findings in the appropriate systems.
/p /li lipSupport audit and inspection readiness by ensuring study files are reviewed according to applicable schedules and procedures.
/p /li lipEnsure assigned activities are completed on time and to a high-quality standard, proactively communicating potential risks to project leads.
/p /li lipProcess and maintain clinical trial documentation within the electronic Trial Master File (eTMF).
/p /li lipReview eTMF documentation and support the resolution of missing, incomplete, or outstanding documentation.
/p /li lipAnalyze findings reports and assist with the clarification and resolution of site documentation findings.
/p /li lipSupport the preparation, compilation, and distribution of Investigator Site Files (ISFs), pharmacy binders, and study supplies.
/p /li lipAssist with study-specific translations and translation quality control, as required.
/p /li /ul h3Site Activation Regulatory Support /h3 ul lipProvide administrative support for site activation and start-up activities.
/p /li lipWork with internal teams to help ensure site start-up activities remain aligned with the site's activation critical path and project timelines.
/p /li lipSupport regulatory submissions and the tracking of local regulatory documentation.
/p /li lipTransmit required documentation to clients and centralized Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), as applicable.
/p /li lipMaintain accurate and timely records of site communications, contact attempts, follow-ups, and survey responses.
/p /li lipReview survey information to help ensure responses are complete, accurate, and relevant.
/p /li lipSupport effective site follow-up plans and escalated concerns or potential risks appropriately.
/p /li lipLiaise with relevant internal teams to support the timely resolution of investigator queries.
/p /li /ul h3Systems Study Coordination /h3 ul lipProvide support for clinical trial systems such as bActivate, eTMF /b , and other study platforms.




/p /li lipHelp ensure study databases and systems remain accurate and up to date.
/p /li lipMaintain study-specific documentation, team lists, project training requirements, activity plans, and vendor trackers.
/p /li lipSupport Risk-Based Monitoring (RBM) activities where applicable.
/p /li lipAssist with scheduling internal and client meetings as required.
/p /li lipSupport study communications, including document distribution, reports, and project-specific mailings.
/p /li lipCollaborate closely with project team members to achieve targeted study milestones and deadlines.
/p /li lipCommunicate site-related issues and potential risks to appropriate clinical and project colleagues.
/p /li /ul h3What We're Looking For /h3 h3Minimum Qualifications /h3 ul lipHigh school/secondary school diploma or equivalent relevant academic or vocational qualification.
/p /li lipAdditional university-level education in blife sciences, healthcare, or a related discipline /b is an advantage.
/p /li lipPrevious relevant experience may be beneficial; however, candidates who demonstrate the appropriate knowledge, skills, and motivation to develop within clinical research may also be considered.
/p /li lipEquivalent combinations of education, training, and directly related experience may be considered.
/p /li /ul h3Preferred Skills Experience /h3 ul lipStrong organizational skills and excellent attention to detail.
/p /li lipAbility to manage multiple tasks efficiently while working to project deadlines.
/p /li lipAbility to analyze project-specific information and systems to ensure accuracy and completeness.
/p /li lipStrong customer-focused mindset.
/p /li lipFlexibility and adaptability to changing priorities and study timelines.
/p /li lipInterest in developing a strong working knowledge of bICH-GCP /b , applicable Italian and European regulations, and clinical research procedures.
/p /li lipGood written and spoken bEnglish /b , together with proficiency in the local language as required.
/p /li lipEffective written and verbal communication skills.




/p /li lipStrong interpersonal skills and the ability to collaborate effectively with cross-functional and international teams.
/p /li lipGood computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
/p /li lipAbility to quickly learn and confidently work with clinical trial databases and systems.
/p /li lipGood judgment, problem-solving, and decision-making skills.
/p /li lipAbility to follow study-specific procedures and project instructions accurately.
/p /li lipAbility to identify potential risks and escalated concerns or potential risks appropriately.
/p /li lipSelf-motivated with a positive and proactive approach to work.
/p /li lipAbility to work effectively both independently and as part of a team.
/p /li /ul h3Working Environment Travel /h3 pThis position is primarily performed in an boffice and/or home-office environment /b , depending on business requirements.
/p ul lipRegular travel is not a core requirement of the role.
/p /li lipOccasional travel or driving to clinical trial sites may be required depending on study needs.
/p /li lipThe position provides exposure to a wide range of clinical trial activities, systems, and cross-functional teams, supporting continued development within clinical research.
/p /li /ul h3Why Join Thermo Fisher Scientific?
/h3 pWhen you join Thermo Fisher Scientific, you become part of a global team committed to accelerating scientific discovery and improving patient outcomes.
/p pWe offer: /p ul lipAn excellent opportunity to bbuild and develop your career in clinical research /b .
/p /li lipExposure to international clinical trials and global project teams.
/p /li lipHands-on experience across site activation, regulatory documentation, clinical trial systems, and study management activities.
/p /li lipA collaborative and inclusive environment where you can learn from experienced clinical research professionals.
/p /li lipContinuous learning, professional development, and opportunities for career progression.
/p /li lipCompetitive compensation and benefits.
/p /li lipThe opportunity to contribute to clinical research that can make a meaningful difference in patients' lives.
/p /li /ul pThermo 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 /p #J-*****-Ljbffr

📌 Clinical Trial Coordinator (Bologna)
🏢 Thermofisher Scientific
📍 Bologna

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