Clinical Research Associate

Job Overview

Do you like to organise and monitor (inter)national clinical trials in order to assure the quality of the clinical data? Then this could be the opportunity to develop your career at Julius Clinical, the Scientific CRO.

We are looking for a proactive Clinical Research Associate with strong communication and negotiation skills who is willing to travel within Europe.  

You will be working for both investigator initiated studies and international industry driven studies. In the investigator initiated studies you will act primarily as an advisor; and in the industry driven studies, you will be in a steering position. You will be part of the  CRA team, currently existing of seven (7) CRAs, and will report to the CRA Manager.

The CRA will be responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to study protocol, SOPs, applicable laws and ICH GCP guidelines. The CRA may conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out).

Tasks & Responsibilities

  • Monitors clinical research in accordance with the protocol, SOPs, applicable laws and ICH-GCP guidelines, including visit report compilation and follow-up within the set timelines;
  • Collates and verifies the Case Report Forms (CRFs) for completeness and accuracy by verifying the source documents, e.g. medical file, laboratory results;
  • Ensures the correct query process is followed in collaboration with the Data Management team;
  • Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions;
  • Verifies compliance with procedures relating to drug accountability;
  • Develops and maintains an effective working relationship with site staff;
  • Trains investigators and site staff (including laboratory, pharmacy and other staff involved) in the correct implementation of the protocol, the CRF and study-specific procedures;
  • Supports the investigator during inspections by healthcare authorities or audits;
  • Ensures the reliable documentation and archiving of study documents, both at the investigator and ‘in-house’;
  • Participates in and helps to organise meetings for investigators and CRAs;
  • Ensures that information is conveyed effectively between the sponsor, investigator and project team;
  • Collaborates closely with internal and external contacts;
  • Is involved in SOP development, maintenance and training.

Desired Skills & Experience

  • Higher level of education, preferably in an (bio)medical field;
  • Preferably  one year of relevant experience in clinical research;
  • PhD candidates ( with a PhD in relevant  field) are also welcome to apply;
  • Knowledge of legislation and regulations and ICH-GCP guidelines;
  • Effective oral and written communication skills in English and Dutch;
  • Proactive,  strong communication and negotiations skills;
  • Willingness to travel;
  • Ability to work independently as well as in a team matrix organisation.

And...

We offer:
- An open culture in an innovative and dynamic environment with a lot of inspiring colleagues.
- Good working conditions.  

We are located:
- In a beautiful monumental building, close to Slot Zeist.
- Close to public transport e.g. busses and train station Driebergen-Zeist.  

About Julius Clinical

Julius Clinical manages global clinical drug trials that will have a major impact on medicine and make a real difference to people’s lives around the world.  Our unique combination of scientific leadership and operational excellence ensures that the data obtained from the trials is of the highest quality.

This type of demanding research requires more than a ‘one-size-fits-all’ approach. Through our unique fusion of scientific leadership and operational excellence, we take a creative, credible, and smart approach to research. We share risks and responsibilities with our partners, and have the flexibility to respond effectively to the ongoing challenges of innovative clinical trials. Our partners include leading biopharmaceutical and medical device companies, as well as academic investigators. Our internationally recognized key opinion leaders are actively involved in the design, conduct, and interpretation of clinical trials. This scientific expertise and credibility, combined with personal links to peers around the world, means that our company has a truly global reach and sector-leading reputation.

At our beautiful headquarters in Zeist, The Netherlands,  there are currently 160 employees: some are physicians,  some are acknowledged experts in their field of scientific or medical expertise, most have business acumen, and all are dedicated to improving healthcare for people everywhere. At Julius Clinical we recognise that our employees are our capital. Our company culture can be described as dynamic, open, co-operative, motivational, collegial, and inspirational.

Working at Julius Clinical is all about improving healthcare. Our vision is: 

To improve healthcare for everyone with clinical research that is deeply rooted in academic medicine and through operational excellence.

At Julius Clinical, we work hard we work together, we challenge each other on the ‘way it has always been done’, and we look for creative ways to develop and conduct trials so that our clients have the best possible results. But most of all, we share a passion for using Science to better the lives of people around the world.

Join us and share the passion.  

Additional Information

Posted
December 29, 2017
Type
0.8 -1.0 FTE, Permanent
Questions
If you have any further questions, please call Chantal van der Meeren, Recruiter or Margriet van der Beek, CRA Manager, at +31 (0)30-656 9900.

How to apply

Interested in this position? Send your CV and motivation to vacancies@juliusclinical.com