Clinical Research Associate
A global biopharmaceutical company based in Copenhagen is looking for an experienced Clinical Research Associate to join them. This is a large organisation focused on finding solutions for serious unmet medical needs, this is a great place to excel in your clinical career.
- Responsible for evaluation, initiation, monitoring, close-out and other tasks associated with the management of clinical sites.
- Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)
- Serve as primary contact for Clinical Research Organizations/ vendors, Investigators and study coordinators for study related questions.
- In conjunction with study team, support feasibility and site selection process for clinical studies.
- Manage patient recruitment strategies to increase patient randomization into the trial
- Review all Adverse Events/Serious Adverse Events and ensure appropriate documentation is in place and any other safety issues are addressed and communicated.
- Order and coordinate study supplies for clinical studies
- Develop and maintain tracking tools to support management of clinical studies
Skills and Requirements
- Bachelor or nurse degree, preferably in the Life Sciences
- Minimum of 3+ years of experience in the pharmaceutical / biotechnology industry or CRO as a Clinical Research Associate from study start-up to database lock.
- Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials
- Strong working knowledge of Electronic Data Capture, Interactive Voice/Web Response System and
Clinical Trial Management System
- Ability to handle and prioritize multiple studies and projects
- Ability to work effectively in a team/matrix environment
- Fluent in Danish and English, oral and written
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani on 02038542629 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.