Aktuelle Jobs im Zusammenhang mit Clinical Research Associate, - Munich - CROMSOURCE
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Clinical Research Associate
vor 2 Wochen
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Clinical Research Associate
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Clinical Research Associate
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Munich, Deutschland Advanced Resource Managers VollzeitAre you an experienced Clinical Research Associate with considerable clinical research monitoring experience? Are you based in Germany and looking for a new contract role? If so, we are keen to hear from you!Our leading CRO client is recruiting for a CRA to be based in Germany, performing and coordinating all aspects of the clinical monitoring and site...
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Senior Clinical Research Associate
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Clinical Research Associate
Vor 5 Tagen
Munich, Deutschland Vantis Vollzeit**THE ROLE**: Als Clinical Research Associate (M/F/d) unterstützt du die Untersuchung der klinischen Wirksamkeit unserer innovativen digitalen Medizinprodukte maßgeblich. Dabei arbeitest Du eng mit unseren Prüfzentren, unserem Clinical Team sowie externen Dienstleistern zusammen. - Begleite und überwache die operative Durchführung von klinischen Studien...
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Senior Clinical Research Associate
vor 1 Woche
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Junior Clinical Research Associate
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Clinical Research Associate Ii
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Clinical Research Associate
Vor 7 Tagen
Munich, Deutschland GKM Gesellschaft für Therapieforschung VollzeitTHINK BEYOND! - CHOOSE PASSION! - AND IMPROVE YOUR QUALITY OF LIFE. UNSERE PHILOSOPHIE Als moderne CRO schreibt GKM fachliche Kompetenz, Erfahrung, Flexibilität und Kreativität im Arbeitsalltag groß. Durch die Wahrung des Dienstleistungscharakters gegenüber seinen Kunden zeichnet sich das Unternehmen seit vielen Jahren durch Kontinuität und stetiges...
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Clinical Research Associate
Vor 7 Tagen
Munich, Deutschland GKM Gesellschaft für Therapieforschung mbH VollzeitTHINK BEYOND! CHOOSE PASSION! AND IMPROVE YOUR QUALITY OF LIFE. UNSERE PHILOSOPHIE Als moderne CRO schreibt GKM fachliche Kompetenz, Erfahrung, Flexibilität und Kreativität im Arbeitsalltag groß. Durch die Wahrung des Dienstleistungscharakters gegenüber seinen Kunden zeichnet sich das Unternehmen seit vielen Jahren durch Kontinuität und stetiges...
Clinical Research Associate,
vor 2 Wochen
**Location**: Germany any city-home based and site visits **Schedule**:Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Clinical Research Associate (CRA II) or Senior Clinical Research Associate (SCRA). You will be responsible for site management (including start-up), both on-site and remotely across Germany while working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies. You will manage clinical projects to ensure quality, budget, and timelines are met while working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies. The studies you will initially be assigned to will be within Oncology, Respiratory, Medical Device, and Cardiology. Join our team and help us deliver clinical trials that will improve patients' lives. **Main Job Tasks and Responsibilities**: - Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned - Assists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites - May act as Feasibility Associate after appropriate and documented training - Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance - Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data - Manages the investigational products (storage, inventory, dispensing records, packaging, and labeling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site - Cooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues - Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project - Will be the main contact person for the site in order to ensure close follow up - Provides general support to the Clinical Research Division on quality control of clinical data - Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned - Reports to the Head of Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial - Develops training material and gives training in collaboration with the Training & Qualification Management Unit - May assist in contract negotiation with sites on study budget after appropriate and documented training - Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites - May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training. - Guides and supervises Clinical Research Associate I (CRA I) in order to coach and train them on the job **Education and Experience**: - University Degree in scientific medical or paramedical disciplines - Previous proven experience as a CRA, performing on-site monitoring activities - Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements **Specific Role Requirements and Skills**: - Fluent in English and German - Proficiency in Microsoft Office (e.g. Word, Excel, Outlook) - Willingness to travel **Our Benefits**: - Full Benefit Package - Full performance and development process with end-of-year reviews - Employee satisfaction survey - your feedback is important for continuous improvement **The Application Process** - **Who will you be working for?**_ - **About CROMSOURCE**_ - CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do. **Our Company Ethos** Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE a
