Clinical Project Assistant - Clinical Trials Regulatory

Main point of contact for Clinical Trial related communications with Ehical review Boards and Regulatory Authorities on the following aspects: Clinical trial Approvals and Clinical Trial Maintenance.

Qualifications: at least secondary qualification - health related field preferred. Minimum three years clinical research experience in Start up unit (Clinical trial submissions to ERB and RAs).

Extensive knowledge related to ICH/GCP guidelines and applicable local regulations. 

Descripción del Puesto 

Main point of contact for Clinical Trial related communications with Ehical review Boards and regulatory Authorities on the following aspects: Clinical trial Approvals and Clinical Trial Maintenance.

Qualifications: at least secondary qualification - health related fiels preferred. Minimum three years clinical research experience in Start up unit (Clinical trial submissions to ERB and RAs).

Extensive knowledge related to ICH/GCP guidelines and applicable local regulations. 

Ability to learn multiple concepts related to legal, compliance and regulatory matters in clinical research.

Responsabilidades 

Main point of contact for Clinical Trial related communications with Ehical review Boards and regulatory Authorities on the following aspects: Clinical trial Approvals and Clinical Trial Maintenance.

Preparation and submission of Clinical Trial dcocumentation to Ethical review Boards and regulatory Authorities to get appropiate approcals according to current regulations. 

Preparation and submission of Clinical Trial documentation to Ethical Review Boards and Regulatory Authorities for the entire study duration as per local regulation.

Perfil 

Qualifications: at least secondary qualification - health related fiels preferred. Minimum three years clinical research experience in Start up unit (Clinical trial submissions to ERB and RAs).

Extensive knowledge related to ICH/GCP guidelines and applicable local regulations. 

Ability to learn multiple concepts related to legal, compliance and regulatory matters in clinical research.

Application form : Clinical Project Assistant - Clinical Trials Regulatory

Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.

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