Senior Clinical Research Associate
hace 5 días
About Us: CorFlow is a Swiss med-tech start-up founded in 2016 by renowned interventional cardiologists and medical device entrepreneurs. The company recently completed a major financing round which enables the expansion of the clinical program and employee team. At CorFlow, we envision being the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. We are developing a medical device that assess Microvascular Obstructions (MVO) in real-time during PCI and serves as a treatment platform while the patient is still in the cath lab. Our mission is rooted in scientific excellence and driven by compassion for the welfare of Acute Coronary Syndrome (ACS) patients. CorFlow’s 1st generation device has been investigated in a First-in-Human multi-center European clinical trial, and CorFlow recently finished the development of the 2nd generation device which can be used in the next clinical studies. We seek a Senior Clinical Research Associate (SCRA) or Senior Field Clinical Trial Specialist (SFCTS) to support our Europe-based clinical activities, including proctoring, technical case support, and study management tasks for current and future trials. CorFlow is initiating a FDA pivotal trial which will have sites internationally, as well as a second randomized study that will be conducted exclusively in Europe. Job Description: The position includes a diverse set of duties. In addition to your critical role in overseeing and managing clinical trials, you will take on advanced proctoring responsibilities. As a Proctor, you will train study site staff on the correct use of the study device and provide input during live cath lab procedures. Periodic technical case support at investigator sites is also expected to ensure safe and effective use of the CorFlow technology, meeting study protocols. If you are a proactive, collaborative, service-minded, and detail-oriented individual with a passion for advancing medical research and a proven track record in medical device clinical trials, we encourage you to apply. Key Responsibilities Proctoring and Case Support Duties • Train assigned study staff on the correct use of the study device. • Supervise/support the setup of the required site workflow to ensure ideal basis for enrolment and that study images and measurements are collected and of consistent quality. • Maintain detailed proctoring records and documentation. • Assist remotely or on site during live cases by supporting site staff in the correct use of the CorFlow study device and the CIP. • In agreement with CPM, release clinical sites to independent use of the study device. Clinical Trial Support • Manage clinical trial activities in alignment with the clinical project manager (CPM), from study initiation, enrolment to study close-out. • Train and educate site staff on study CIP, the correct use of the study EDC software, the electronic Investigator Site File (eISF), and regulatory requirements. • Conduct site qualification, initiation, monitoring, and close-out visits to ensure CIP adherence and data integrity. • Collaborate with investigators and study site staff to resolve issues and ensure timely and accurate data collection. • Work in close collaboration with the study-assigned CRO (if applicable) Regulatory Requirements Support • Assist in preparing EC/IRB submissions and documents, as needed. • Assist in internal and external audits and inspections at study sites, ensuring compliance with regulatory requirements. Data Management • Ensure accurate and timely data collection in eCRF, monitoring, and validation according to the CIP and associated documents. • Collaborate with data management team and clinical sites to resolve subject data discrepancies. Desired Qualifications • Bachelor's degree in a relevant life science or healthcare field, master’s degree preferred. • Relevant experience as Clinical Research Associate, Clinical Field Trial Specialist, Field Technical Specialist or similar in the medical device or CRO industry. • Proven experience in proctoring and site management preferred. • Fluent French and/or, Spanish and/or Italian (both written and spoken) . • Fluent English (both written and spoken) • Good knowledge of GCP, ISO 14155, and relevant EU regulatory requirements. • Strong organizational skills and attention to detail. • Good communication and interpersonal skills. • Ability to work independently and collaboratively in a fast-paced environment. • Proficiency in using CTMS and EDC software solutions. • Proficiency in additional languages (Italian, German, and/or Spanish) are preferred. • Willingness to travel 60-80% within EU. Benefits: We offer a full-time contract with a competitive package and career opportunities in a pioneering start-up environment. Please note: for this position we do not accept CVs through recruiters. How to Apply: If you possess the required experience and qualifications and want the challenge of growing with our company, please submit your application including your latest resume, cover letter and/or a short personal video* (max 2 min) with your motivation. Sara Specchia | HR Manager | sspecchia@corflow.ch | +41 76 216 27 53 *video download link preferred Corflow Therapeutics AG is an equal employment opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment and advancement opportunities are available to all individuals regardless of their race, color, national origin, religion, ancestry, citizenship status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, or any other protected characteristic. Note: This job description is intended to provide a general overview of the responsibilities and qualifications for this position. It is not an exhaustive list, and duties may evolve over time based on the needs of the organization.
-
Clinical Research Associate
hace 7 meses
España MRL Consulting Group A tiempo completo**Senior Clinical Research Associate** **About Us**: **MRL Consulting Group** is partnered with a leading contract research organization dedicated to advancing the field of oncology research. They are committed to conducting groundbreaking clinical trials that lead to the development of innovative cancer treatments. Our mission is to improve the lives of...
-
Clinical Research Associate-1 Year
hace 2 semanas
España NonStop Consulting A tiempo completoEstoy trabajando con una CRO de tamaño medio que ha doblado su plantilla a nível internacional y en España en el ultimo año y buscan a un Clinical Research Associate para su oficina de Madrid. Ofrecen muchas oportunidades de desarrollo profesional debido al momento en el que se encuentran y a su tamaño. Ademas aunque se trata de una vacante homebased la...
-
Clinical Research Associate
hace 2 días
España EPM Scientific A tiempo completoWe are seeking an experienced Clinical Research Associate to join our team in Spain. The ideal candidate will have at least 3 - 5 years of Clinical trial experience in oncology studies. Key Requirements: Experience in Phase 1 oncology studies is required Based in Barcelona or Madrid Competitive salary, rate negotiable based on experience Start date: February...
-
Clinical Research Associate
hace 2 días
España EPM Scientific A tiempo completoWe are seeking an experienced Clinical Research Associate to join our team in Spain. The ideal candidate will have at least 3 - 5 years of Clinical trial experience in oncology studies. Key Requirements: Experience in Phase 1 oncology studies is required Based in Barcelona or Madrid Competitive salary, rate negotiable based on experience Start date: February...
-
Clinical Research Associate
hace 1 día
España Epm Scientific A tiempo completoWe are seeking an experienced Clinical Research Associate to join our team in Spain. The ideal candidate will have at least 3 - 5 years of Clinical trial experience in oncology studies. Key Requirements: Experience in Phase 1 oncology studies is required Based in Barcelona or Madrid Competitive salary, rate negotiable based on experience Start date: February...
-
Clinical Research Associate
hace 1 mes
España Thermo Fisher Scientific A tiempo completoJob Description Clinical Research Associate I/II - Barcelona At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...
-
Clinical Research Associate
hace 7 meses
España Avania A tiempo completoAvania Clinical is a leading contract research organization (CRO) that offers exciting career opportunities for professionals in the clinical research industry. With a global footprint, a diverse range of therapeutic areas, and expertise in supporting medical device and MedTech solutions, Avania Clinical provides a dynamic and rewarding work environment that...
-
Senior Clinical Research Associate
hace 2 meses
España Tfs Healthscience A tiempo completoAbout this role TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions. The Clinical Research Associate (CRA) is...
-
Clinical Research Associate
hace 4 semanas
España TFS HealthScience A tiempo completoTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.Join Our Team as a Clinical Research Associate (CRA)About...
-
Clinical Research Associate
hace 2 meses
España Tfs Healthscience A tiempo completoTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Clinical Research Associate (CRA) About...
-
Junior Clinical Research Associate
hace 6 días
España Medpace, Inc. A tiempo completoJob Summary: The Clinical Research Associate at Medpace is offering the unique opportunity to have an exciting career in the research of drug and medical device development. For those with medical and/or health/life science interest and background who want to explore the research field, and be part of a team bringing pharmaceutical and medical devices to...
-
Senior Associate Clinical Contracts
hace 4 semanas
España Amgen Inc. (IR) A tiempo completoSenior Associate Clinical Contracts & Budgets Apply remote type: Flex Commuter / Hybrid Locations: Spain - Barcelona Time type: Full time Posted on: Posted 2 Days Ago Career Category: Clinical Development Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared...
-
Senior Clinical Research Associate
hace 5 días
España IQVIA Argentina A tiempo completoSenior Clinical Research AssociateIQVIA is the Human Data Science Company oriented to drive human health outcomes forward.When you join IQVIA Spain as a sponsor-dedicated CRA, you’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers.With access to world-class...
-
Clinical Research Associate
hace 1 mes
España Opis S.r.l. A tiempo completoAs a Clinical Research Associate (CRA), you are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trials according to the study protocol, ICH-GCP, applicable regulations, guidelines, and sponsor requirements.Some of what you will do:Identify investigator sites and participate...
-
Clinical Research Physician
hace 1 mes
España Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing clinical cancer research.TRIO is looking for a Clinical Research Physician to join our Medical Monitoring Unit team. Reporting to the Medical Monitoring Unit Manager, this will be a home-based, full-time position in Spain.Main...
-
Clinical Research Physician
hace 1 mes
España Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing clinical cancer research.TRIO is looking for a Clinical Research Physician to join our Medical Monitoring Unit team. Reporting to the Medical Monitoring Unit Manager, this will be a home-based, full-time position in Spain. Main...
-
España ARES CONSULTORES A tiempo completoRemoto: Trabajo híbridoJob DescriptionVacante: CRA (Clinical Research Associate)Descripción:Garantizar el cumplimiento del protocolo del ensayo clínicoAsegurar la protección de los derechos, la seguridad y el bienestar de los sujetos del estudio humanoVerifica las actividades del sitio clínicoRealizar visitas in situRevisa los formularios de informes de...
-
Senior Associate Clinical Contracts
hace 4 semanas
España Amgen SA A tiempo completoHOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering...
-
Clinical Research Associate
hace 2 meses
España Vhir A tiempo completoAcademic Research Organization (ARO) VHIR offers a vacant position within its Academic Research Organization for a Clinical Research Associate (Coordinator Sponsor Activities) in research projects related to the "PROYECTOS DE INVESTIGACIÓN CLÍNICA INDEPENDIENTE" file number ICI22/00106, funded by ISCIII and co-funded by FEDER, according to the call...
-
Lead Clinical Research Associate
hace 7 meses
España United Biosource Corporation A tiempo completoUBC are currently recruiting within our clinical leadership team, we are looking to recruit a Lead CRA within the EU. UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the...