Clinical Research Associate
hace 2 días
As 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 in the feasibility process for new studies.Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., ICH GCP.Perform visits remotely according to foreseen applicable procedures and timeframes.Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission.Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets.Check the correct submission and completion of informed consent forms.Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution.Verify that serious adverse events have been reported using a SAE form, according to OPIS and/or Sponsor procedures.Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion.Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.Requirements:Enthusiastic, knowledgeable, and proactive.University degree in a scientific/life science field.At least 2 years of experience in managing and conducting clinical trials.In-depth knowledge of ICH GCP principles.Able to carry out independently all the activities related to the monitoring of clinical trials.Good knowledge of Office Suite (Word, Excel, PowerPoint).Organizational and problem-solving skills.Excellent written and verbal communication skills including a good command of the English language.No restrictions to travel onsite.Who we are:Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science-driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.What we offer:We offer a competitive salary with other benefits/bonuses and the opportunity to develop your professional career with an expanding and growing company.Please read the information notice on the processing of personal data in the candidates' information section of our company website.Candidate Privacy Policy
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Clinical Research Associate
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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...
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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...
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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...
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Clinical Research Physician
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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...
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España Rho, Inc. A tiempo completoOverviewJoin us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.At Rho, we’re committed to you just as you’re committed to us. You’ll have the...
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hace 2 semanas
España buscojobs España A tiempo completoAt TFS HealthScience, we are dedicated to advancing clinical research through innovative solutions and a commitment to quality. We provide tailored services across the clinical development lifecycle to deliver impactful results for our clients and the healthcare industry.Role Overview :We are looking for a Clinical Trial Associate to support TMF archiving...
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Clinical Trial Associate
hace 3 semanas
España Tfs Healthscience A tiempo completoAt TFS HealthScience, we are dedicated to advancing clinical research through innovative solutions and a commitment to quality. We provide tailored services across the clinical development lifecycle to deliver impactful results for our clients and the healthcare industry. Role Overview: We are looking for a Clinical Trial Associate to support TMF archiving...
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Senior Clinical Research Associate
hace 2 días
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Associate Clinical Project Manager
hace 4 semanas
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Research Associate
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hace 6 meses
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hace 3 días
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hace 6 meses
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