Clinical Research Coordinator

Clinical Research Coordinator

Would you like to be part of a growing Swedish biopharma company?
Hansa Biopharma is a fast-growing biopharmaceutical company developing novel immunomodulatory enzymes for transplantation and acute autoimmune diseases. The lead product, imlifidase, is a proprietary antibody-degrading enzyme currently in late-stage clinical development for kidney transplant patients, with significant potential for further development in other solid organ transplants and in acute autoimmune indications. The company also has a strong pipeline of preclinical projects that may provide a second wave of potential drugs.

In the role as Clinical Research Coordinator you will be involved in the day-to-day management of our clinical studies, working closely with and supporting the Clinical Research Manager (CRM) with all the various parts from planning and executing to completion of a clinical study. Responsibilities involves, among other things, overseeing and working closely with the study monitor to manage the clinical sites. We would like the candidate to have at least five years of previous experience within clinical research and GCP from the pharma industry, preferably with monitoring experience.

You will be involved in several projects and studies simultaneously and report to the Director of Clinical Operations as well as to the respective project manager for project activities.

By being a part of our cutting-edge research, you will be making a tangible impact for patients as well as being part of the exciting journey Hansa Biopharma has embarked upon. The role will give you the opportunity of broadening your area of expertise and we would positively support your development to the role of CRM if this is part of your career plan and you demonstrate the potential.

It is a temporary position during 12 months (due to maternity leave), full time and located in Lund.

Responsibilities:
  • Clinical site management by working closely with and overseeing monitoring activities
  • Continuous review of electronically captured data for clinical studies
  • Create working manuals (i.e. monitoring manuals) and other documentation
  • Review and approve monitoring reports
  • Co-monitoring
  • Coordinate and manage activities at sites, i.e. hospitals, Phase I units etc. This might require that you travel from time to time.
Requirements:
We are looking for a candidate with at least a master's degree within the life sciences or a research nurse.

Moreover, we require that you have:
  • Five years of previous experience within clinical research from the pharma industry and GCP, preferably with monitoring as well as experience from working with electronic case report forms (eCRF)
  • Fluent skills in English
  • Background within immunology is a plus
We put great emphasis on you being well structured and thorough in your way of working. You enjoy communicating and collaborating with others and since you will be working with different projects in parallel, we also expect you to be flexible and open minded to changes in your day to day business.

The atmosphere is open-minded and together with your team colleagues you strive to make further contributions to Hansa Biopharma´s field of research!

We offer:
  • A position in a company that makes a difference today; in completed and ongoing clinical studies, the Hansa Biopharma lead candidate imlifidase has enabled kidney transplantation in highly sensitized patients with chronic kidney disease.
  • An opportunity to be part of the journey during which Hansa Biopharma aims to bring lifesaving products to the market.
  • A creative and positive atmosphere
  • Friendly, motivated and skilled colleagues
Application
If you find this position to be of interest, you are welcome to submit your application.

For more information about the position, please contact Elisabeth Sonesson, Director of Clinical Operations, at elisabeth.sonesson@hansabiopharma.com

Last day of application: April 26
Start date: as soon as possible

We are looking forward to receive your application, you are needed!
Mer info
Område Lund
Yrkesroll Hälsa & Sjukvård, Medicin & Farmaci
Typ av anställning Heltid
Sista ansökningsdag 26 apr 2019 (8 dagar kvar)
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Om arbetsgivaren

Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company's lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute autoimmune indications.

Hansa also has a strong pipeline of preclinical projects, including NiceR, through which the Company is developing novel immunoglobulin-cleaving enzymes for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden, and its shares are listed on NASDAQ Stockholm (HMED).