Regulatory and Start Up Specialist
hace 5 días
Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Home Based role that requires Spanish language fluency. Essential Functions Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. Prepare site regulatory documents, reviewing for completeness and accuracy. Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Review and provide feedback to management on site performance metrics. Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. Inform team members of completion of regulatory and contractual documents for individual sites. Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines. Provide local expertise to SAMs and project team during initial and on-going project timeline planning. Perform quality control of documents provided by sites. May have direct contact with sponsors on specific initiatives. Qualifications 1-year clinical research experience within submissions. Equivalent combination of education, training and experience. #J-18808-Ljbffr
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Regulatory and Start Up Specialist
hace 1 día
Madrid, España IQVIA A tiempo completoRegulatory and Start Up Specialist Join to apply for the Regulatory and Start Up Specialist role at IQVIA . Home Based role that requires Spanish language fluency. Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures...
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Regulatory and Start Up Specialist
hace 1 día
Madrid, España IQVIA A tiempo completoRegulatory and Start Up SpecialistJoin to apply for the Regulatory and Start Up Specialist role at IQVIA .Home Based role that requires Spanish language fluency.Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures...
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Regulatory and Start Up Specialist
hace 5 días
Madrid, España IQVIA LLC A tiempo completoRegulatory and Start Up Specialist page is loaded## Regulatory and Start Up Specialistlocations: Madrid, Spain: Barcelona, Spaintime type: Full timeposted on: Posted Todayjob requisition id: R **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations,...
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Regulatory and Start Up Specialist
hace 1 día
Madrid, Madrid, España Precision for Medicine A tiempo completoPrecision for Medicine is a Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition...
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Regulatory and Start Up Specialist
hace 5 días
Madrid, España IQVIA A tiempo completoJob OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Home Based role that requires Spanish language...
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Regulatory Affairs Study Start Up Specialist II
hace 3 días
Madrid, España CTI Clinical Trial and Consulting Services A tiempo completoRegulatory Affairs Study Start Up Specialist II (RASSU) Join to apply for the Regulatory Affairs Study Start Up Specialist II (RASSU) role at CTI Clinical Trial and Consulting Services What You’ll Do Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS. Handle regulatory submissions for medical devices, GMOs,...
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Start Up Specialist
hace 7 días
Madrid, Madrid, España Fortrea A tiempo completoJoin Our Team and Drive Clinical Research SuccessAt Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will...
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Regulatory Affairs Study Start Up Specialist II
hace 1 semana
Madrid, España Consulting, Inc. A tiempo completoRegulatory Affairs Study Start Up Specialist II (RASSU) Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS. Handle regulatory submissions for medical devices, GMOs, and local country requirements in countries where CTIS is not mandated, including ethics committee submissions. Prepare and QC Clinical Trial...
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QA & RA Specialist, IVD Start-up — Barcelona
hace 5 días
madrid, España Barrington James A tiempo completoAn innovative IVD start-up in Madrid is looking for a Junior QA / RA Specialist to establish their Quality & Regulatory function. The role involves supporting ISO 13485 compliance, preparing regulatory submissions, and engaging with Notified Bodies. Ideal candidates should have 3-5 years of experience in QA / RA, knowledge of EU IVDR and ISO 13485, and...
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Study Start Up Associate
hace 17 horas
28224 Pozuelo de Alarcón, Madrid provincia, España ICON Plc A tiempo completoStudy Start Up Associate II - Fluent Dutch Required ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Study Start Up Associate / Regulatory...