Senior CRA - Netherlands

Location Netherlands
Discipline: Clinical Operations, Clinical Research
Job type: Permanent
Salary: £€ DOE
Contact name: Harry Henson

Contact email: harry.henson@rbwconsulting.com
Contact phone: +44 (0)1293 364 092
Job ref: 30345B
Published: 3 months ago
Expiry date: 28 Dec 2023 11:59
Startdate: ASAP

​RBW Consulting are delighted to be partnered with one of our regular collaborators, a small CRO headquartered in Belgium, to assist them in their expansion in to The Netherlands. They are looking for CRAs in The Netherlands at both junior and senior level who can become their second hire in the country and add value to their current and upcoming projects. 

The CRO is a client we have worked with for many years now and they are one of our most exciting partners. Their client base predominantly focuses on the small sized Biotech market, while also working with a couple of the industries giants. Working at this CRO gives you the opportunity to work with some of the most exciting companies in the clinical trial space, while also gaining the benefit of having a hands on CEO who is always happy to provide support and advice where needed.

The  CRA will oversee the progress of a clinical trial, and should ensure that it is conducted, recorded, and reported to a high quality in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.


Responsibilities 


  • To act as main point of communication between sponsor, site staff and any third party.

  • To ensure that the study is conducted and documented in compliance with the approved protocol/amendment(s), with GCP and with all applicable regulatory requirements.

  • To work according to the applicable quality management system.

Tasks

  • To perform submissions to Ethical Committees and Regulatory Authorities: initial submissions, notifications, amendments and safety information amongst other.

  • To prepare, conduct and report feasibility studies.

  • To prepare, conduct and report site selection, initiation, monitoring and close-out visits.

  • To build and maintain good collaboration with investigators and site personnel.

  • To ensure that sites are prepared and ready to conduct the study in relation to training, study supplies, medication amongst other.

  • To verify source data and CRF on completeness and correctness.

  • To perform source data verification in compliance with the requirements as set out in the monitoring manual.

  • To monitor the conduct and progress of the study.

  • To collect, maintain all required essential documents.

  • To verify IP ordering, shipments, storage and accountability.

  • To verify whether safety reporting requirements are met: SAE, SUSAR, line listings.

  • To report adequately and timely to the appropriate person on the progress of the trial and on any item requiring follow-up.

  • To coordinate communication between site staff and any other party.

  • To participate in international study teams.

  • To work, when possible, in a pro-active /anticipating manner to avoid problems from occurring.

  • To work in accordance with the specified quality system for the study and to adhere to the study timelines.

  • To coordinate audit and inspection preparation activities when required and ensure that corrective and preventive actions are implemented.

  • Maintain personnel dossier (training records and CV) up to date

  • To participate on department-wide tasks to contribute to the optimization of processes within the department.

  • Any other task that may be requested as far as can reasonably be expected, including those tasks that are linked to the job description of the Clinical Trial Assistant (CTA).

If this sounds like an opportunity you would like to hear more about then please don't hesitate to apply and Harry Henson will reach out to discuss your application further!