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Senior CRAs for BE/NL
Eingestellt von Amoria Bond Ltd
Gesuchte Skills: Client
Projektbeschreibung
Senior Clinical Research Associate (Brussels)
Clinical Research Associate
CRA Project management, Senior Clinical Research, Clinical Research Associate, Pharmaceutical, Biotech, freelance, Netherlands, Clinical research, Senior CRA
My client is a CRO looking for a broad experienced CRA with experience in oncology and preferably cardiology (device studies). This is an interim assignment of 8 months, and you will work on a number of different studies. Looking for someone to start ideally January and ready to hit the ground running.
The successful Clinical Research Associate
. Degree level education in Health Sciences or a relevant discipline and/or considerable knowledge working as a Clinical Research Associate
. Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) for research sites in compliance with the approved protocol
. Experience in clinical study protocol development and ethical submissions
. Excellent communication skills for ongoing communication with the medical site staff (coordinators, clinical researchers and their site staff)
. Advanced proficiency in English, Dutch and preferably French.
The Role
. 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.
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.
Clinical Research Associate
CRA Project management, Senior Clinical Research, Clinical Research Associate, Pharmaceutical, Biotech, freelance, Netherlands, Clinical research, Senior CRA
My client is a CRO looking for a broad experienced CRA with experience in oncology and preferably cardiology (device studies). This is an interim assignment of 8 months, and you will work on a number of different studies. Looking for someone to start ideally January and ready to hit the ground running.
The successful Clinical Research Associate
. Degree level education in Health Sciences or a relevant discipline and/or considerable knowledge working as a Clinical Research Associate
. Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) for research sites in compliance with the approved protocol
. Experience in clinical study protocol development and ethical submissions
. Excellent communication skills for ongoing communication with the medical site staff (coordinators, clinical researchers and their site staff)
. Advanced proficiency in English, Dutch and preferably French.
The Role
. 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.
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
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung