Clinical Research Associate (CRA) - Phase I

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Ørestad

We are looking for an experienced Clinical Research Associate (CRA). The ideal candidate will have significant experience in conducting trials, including Phase 1 trials . As a CRA working with [xxxxx], you will have the opportunity to make a difference to patients’ suffering from chronic diseases, such as kidney diseases. If you are eager to make a real impact, and you are ready for a fulfilling career, this may be the perfect opportunity for you. Don’t hesitate any longer and apply to the role! The Position In this exciting role you will manage clinical trials, including phase I trials in accordance with company’s policies and procedures, relevant legislation and ICH GCP requirements whilst maintaining the standards of the [xxxxx]. You will collaborate closely with clinical investigative site teams to deliver our clinical trials according to target. In addition, you will be:
  • The main line of communication with investigator site teams
  • Conducting and documenting monitoring visits in accordance with the Monitoring Plan, using risk-based quality principles
  • Conducting training sessions for colleagues concerning e.g. site initiation, monitoring, inspection readiness and site closure
  • Managing protocol compliance, trial product handling and data entry requirements at site
  • Travel will be required approximately 20-25% of the time. Qualifications You are a very collaborative team player who is proactive and ready to help in challenging situations. You bring minimum of 5 years of experience of monitoring trials as well as healthcare industry knowledge and willingness to coach and mentor junior colleagues. Moreover, you have the following requirements:
  • Bachelor's Degree level, life science or nursing qualification or equivlant.
  • Relevant experience and an excellent understanding of clinical trial procedures – ICH GCP, regulatory issues, SOPs
  • GCP Certification
  • Good working knowledge of electronic clinical trials systems – such as; Veeva Vault, IWRS, electronic TMF
  • Preference will be given to candidates with experience and knowledge of site audits and inspections
  • Knowledge of clinical trials within the field of kidney diseases will be considered an advantage
  • Experience in conducting instructional sessions for colleagues will be considered an advantage
  • Excellent level of Danish and English
  • About the Department [xxxxx]’s Danish affiliate has 5 clinical therapy areas (TAs) and each area has a dedicated team of Trial Managers, Clinical Research Associates and Clinical Trial Administrators. There are currently 18 CRAs across the areas who form a strong CRA community. Each TA has a specific clinical focus and is responsible for conducting high quality clinical trials in Denmark. We are part of a regional team of 8 European countries and work closely with global Trial Managers. Our department has a very open and honest culture with a fantastic team spirit. We work hard, but always finds time to have fun together. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact If you have any questions, please contact Anne Louise Wulff, Head of Therapeutic Area OSCD & Phase I at [xxxxx] Deadline Please, apply before 30-03-2024 You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".

    Arbejdsstedet er beliggende i Ørestad.

    Jobbet er oprettet på vores service den 12.3.2024, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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