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Herakles Pharma

Senior Clinical Research Associate in Dordrecht fulltime

Functiegroep: Clinical Operations
Locatie:Dordrecht
Werkweek:40 uur
Procedure: W&S
Vacature ID:#901
Publicatiedatum:07-01-2020

Senior Clinical Research Associate in Dordrecht fulltime

De organisatie

Our client is a small sized Contract Research Organization. They are active in more than 15 countries with approximately 35 employees. Due to further growth and plans to expand further the upcoming years they are seeking an experienced Clinical Research Associate. The studies you can be assigned to can vary from phase I to IV on various indications such as orphan diseases, oncology, cardiology, dermatology or other indications.

De functie

As a senior Clinical Research Associate you independently work on more complex clinical research projects according to companies and/or Sponsor Standard Operating Procedures, ICH-GCP, FDA and other applicable guidelines. You are responsible for conduct of feasibility, pre-study and initiation visits, all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, liaise with vendors and for all aspects of site management as prescribed in the project plans.

Het profiel

Qualifications for the function as a (Sr) Clincial Research Associate:

  • Related degree, preferably in science or health related discipline;
  • Minimum of 5 years experience in monitoring and conducting global clinical research within GCP/ICH and local guidelines, laws and requirements;
  • Extensive knowledge of clinical trial monitoring, Ethics Committee and Competent Authority submissions and all applicable regulations and guidelines;
  • Experience with Site contract negotiations is a plus;
  • Strong organizational, time management, and problem solving skills and the ability to work independently;
  • Time management skills with the ability to manage multiple activities, setting priorities and meeting timelines;
  • Superior interpersonal skills, able to work within a multicultural environment and assertively deal with (difficult) situations;
  • Fluent in Dutch and English, spoken and written;
  • IT skills.

Het aanbod

  • A very good base salary;
  • Every year an increase;
  • Pension plan without a contribution from your side;
  • Much flexibility, also to work from home;
  • Phone, laptop and home equipment.

Inlichtingen bij

Interested in this position as a (Sr) Clincial Research Associate? Please respond via this page. You can also contact Leonie Koomen via leonie@heraklespharma.nl / 0610518323.