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Traineeship Clinical Research Associate

Do you want to be involved in all aspects that come with obtaining and maintaining market approval in the MedTech industry? Do you like to keep things simple, while never losing sight of quality? And are you excited to support the growth story of our company? Join our team! 

We are actively offering traineeships for individuals who aspire to become Clinical Research Associates (CRAs).

Company Profile

BeVinced is an emerging Clinical Research Organization (CRO) with solid expertise in medical device trials. We support manufacturers getting their devices on the market and keeping them there safely, effectively and affordably. Clients range from start-up companies initiating first-in-man studies, to more emerging companies focusing on their post-market clinical follow-up activities.

BeVinced was founded early 2023. The founders have over 30 years experience in the MedTech CRO Industry. Together with former co-workers a team was formed that has worked together for over a decade and contributed to the successes of many medical device projects.

Job Profile

As a trainee CRA, you: 

  • Set up and coordinate clinical trials, train study sites, perform site visits. 
  • Verify that the rights, safety and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. 
  • Make sure that the trial is conducted in compliance with the currently approved protocol, Standard Operating Procedures, ISO14155 and applicable regulatory requirements. 

Tasks and Responsibilities

  • Support in development of various documents, such as: informed consent forms, study protocol, case report forms, study plans.  
  • Develop and maintain study files and project trackers.  
  • Prepare submissions to Ethics Committees and National Competent Authorities under supervision and assist in administrative tasks for submissions. 
  • Support investigator selection procedures. 
  • Support in site start-up: prepare clinical trial agreements, provision of clinical trial supplies and training of site staff (initiation visits).  
  • Monitoring the trial: verifying that data provided is consistent with patient clinical notes. This task will involve visiting the study sites throughout Europe on a regular basis. 
  • Closing down study centers on completion of the trial (close out visits) 

The focus is on training on all aspects related to conducting MedTech clinical trials.  

Job Prerequisites

  • Master degree (or equivalent) in (para)medical, scientific or nursing discipline 
  • Preferably ISO14155 (or ICH-GCP) knowledge 
  • Availability to travel domestically and internationally (Europe) for up to 8 days/month 
  • Proficient in the use of computer and software systems 
  • Fluent in English (spoken and written) and preferably adequate knowledge of a second language (besides Dutch) 
  • Availability of 0.8 – 1 FTE
  • In order to ensure a smooth onboarding process, we expect a minimum presence of 80-100% at our office in Amsterdam during the first 6 months
  • Competenties: structured, detail-oriented, stress resilient, excellent communication skills, flexible 

We offer the opportunity to:

  • … become part of a knowledgeable and enthusiastic team of MedTech experts
  • … work in the dynamic environment of an emerging company
  • … be involved in and be responsible for all aspects of MedTech trials
  • travel internationally throughout Europe  
  • … work in an elegant canal house in Amsterdam city center

For more information please contact Marloes van Laarhoven:

careers@bevinced.com
+31 20 215 3553

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