Start Up Specialist Site Readiness and Reg Specialist II FSPx Team Spain
hace 2 días
Join 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 help bring life-changing treatments to patients faster.In this role you will be part of our FSPx team and work directly with one of our renowned key sponsors to advance the development of innovative life-changing medications.Key ResponsibilitiesServe as the primary contact for investigative sites during start-up and maintenance activities.Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.Prepare and submit regulatory documents including country-specific application forms and informed consent forms.Track submission timelines and proactively address potential delays.Collaborate with internal and external stakeholders including vendors, clinical teams, and regulatory authorities.Ensure all documentation is audit‑ready and systems are consistently updated.Assist in the negotiation of site contracts and budgets if applicable.Provide mentorship and training to new hires and less‑experienced colleagues.Required QualificationsUniversity/College degree (life sciences preferred) or certification in a related allied health profession.Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start‑up processes.Ability to review and adapt patient informed consent forms to meet local and protocol‑specific requirements.Experience interacting with regulatory authorities and site start‑up teams.Excellent organizational, problem‑solving, and communication skills.Proficiency in Microsoft Office and document management systems.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.What We OfferCompetitive salary and performance‑based incentives.Flexible work arrangements (remote/hybrid options).Professional growth opportunities in a collaborative and innovative environment.The opportunity to work on cutting‑edge clinical research projects.Learn more about our EEO & Accommodations request here.Employment Type: Full‑TimeExperience: 2+ yearsVacancy: 1#J-18808-Ljbffr
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Start Up Specialist
hace 4 días
madrid, España Fortrea A tiempo completoStart Up Specialist / Site Readiness and Reg Specialist II - FSPx Team - Spain Fortrea, Madrid, Community of Madrid, Spain Join Our Team and Drive Clinical Research Success! At 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...
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madrid, España Fortrea A tiempo completoJoin Our Team and Drive Clinical Research Success! At 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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Site Start-Up
hace 4 días
Madrid, España Fortrea A tiempo completoA leading clinical research organization in Madrid is seeking a Site Start-Up Specialist. In this role, you will coordinate site start‑up activities, manage essential regulatory documents, and ensure compliance with ICH/GCP guidelines. Ideal candidates should have a university degree in life sciences, a minimum of 2 years in clinical research, and strong...
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Site Start-Up Specialist
hace 2 días
madrid, España Fortrea A tiempo completoA leading clinical research organization in Madrid is seeking a Site Start-Up Specialist to coordinate site start-up activities and manage regulatory submissions. In this role, you will ensure compliance with ICH/GCP guidelines and collaborate with stakeholders to advance innovative treatments. Applicants should have at least 2 years of clinical research...
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Madrid, España Precision Medicine Group 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...
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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...
