Descrizione:
Job Description SummaryThe Clinical Trial Coordinator assists the clinical research team, ensuring the study is conducted in accordance with GCP, SOP, protocol, and respecting budget and timelines. The Coordinator manages start-up activities and documents management.Key ResponsibilitiesResponsible (under PM oversight) for start-up activities, including ethics and regulatory submission at national and international level and site contracts negotiation.Responsible for ISF preparation and TMF set up and maintenance (under PM oversight).Maintains relationships with ECs and CA.Supports sites/vendors invoicing management and tracks invoicing as required.Collaborates on preparation of weekly/monthly and ad hoc project reports, updates CTMS, maintains study-specific trackers.Supports CRA activities follow-up.Supports document translation, if required.Participates in internal, client/sponsor, scientific, and other meetings as required and participates in audit.Performs additional duties as assigned.Desired Qualification & ExperienceGraduation in scientific/health field.Previous experience in clinical research (CROs, Pharma, or academia/hospital).Good knowledge of ICH GCP and appropriate regulations.Good knowledge of clinical research and regulatory/ethical requirements.Technical Competences & Soft SkillsEnglish proficiency.Good MS Office Suite skills.Professional, trustworthy, quality focused; careful, thorough, detail-oriented.Strong organizational skills with ability to multitask and work effectively in fast-paced environment; manage priorities and time.Strong analytical skills.Strong communication and interpersonal skills with customer-service orientation.LanguagesEnglish.EducationBachelor of Science (BS) Life Sciences.Bachelor of Science (BS) Pharmacy.Contract TypeRegularSalary Range€30,000 - €35,000 (final offer determined within location-specific range based on confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope).BenefitsProfessional development.Global travel.Flexible work programs. #J-18808-Ljbffr