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Junior/Intermediate Clinical Research Associate

Eingestellt von Amoria Bond Ltd

Gesuchte Skills: Client

Projektbeschreibung

Junior/Intermediate Clinical Research Associate

Clinical Research Associate (Study-Startup experience a bonus)

CRA, Medical device, Clinical Research, Clinical Research Associate, Pharmaceutical, Biotech, freelance, Belgium, Clinical research, Study startup

My client is a medical device company looking for junior-intermediate Clinical Research Associates (CRA) to work on several studies. The successful Clinical Research Associate(s) will ideally have study startup experience, as my client is looking to get some hands-on practical individuals who will have a lot of operational work.

The successful Clinical Research Associates will have

. Degree level education in Health Sciences or a relevant discipline and/or adequate experience working as a Clinical Research Associate
. Some clinical research monitoring experience (including routine monitoring and closeout visits) for research sites in compliance with the approved protocol
. Experience in clinical study protocol development and ethical submissions is preferred
. Excellent communication skills for ongoing communication with the medical site staff (coordinators, clinical researchers and their site staff)
. Advanced proficiency in English

The Role

. 32-38 hours per week (2 days at the office, rest homebase)
. Usual start-up activities
. Monitor clinical trials to ensure absolute adherence to good clinical practice in accordance with ICH-GCP standards.
. Site management to ensure adequate adherence to protocol, source data verification and assess CRF entries
. Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
. Liaise with the Medical Monitor, Principle Investigator, Clinical Operations staff and sponsor representatives as required
. Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
. Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements

Get in touch

If you think you meet the criteria for this role, please apply to this post or forward your CV to me directly at (see below)

Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.

Projektdetails

  • Einsatzort:

    Leuven, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    18 weeks

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

Amoria Bond Ltd

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