Ref #: 25199

Employment type: Permanent - Full-Time

Location: Romania

Posted: 13-Nov-2020

Description

As a Clinical Trial Assistant you will support the Local Trial Manager and CRAs to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials. You will perform regulatory document review and approval, including site specific Informed consents and ensuring that all trial related activities are in compliance with SOPs, and company policies.



Responsibilities:

Provide initial support to Local Trial Manager (LTM) by distributing and tracking investigator feasibility questionnaires
Upon selection of investigator sites, the CTA will be responsible for the collection and review of regulatory documents for accuracy and completeness at study start up as well as throughout study
Communicates with sites on document updates and corrections
Liaise with Site Managers ( CRA’s) on trial documents and study site readiness
Interacts with LTM in order to obtain approval of informed consent changes to ensure study timelines are met
Maintains Trial Master File (IF) either paper or eTMF.
Establishes and maintains good working relationships with the site investigational staff.


EXPERIENCE REQUIREMENTS

Preferentially 1-2 years relevant clinical trial experience or equivalent.
Excellent knowledge of English language.
Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
Strong interpersonal and negotiating skills.
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.


HOW TO APPLY:

This is an exceptional opportunity within a top pharmaceutical company who offers rewarding careers. If you want to be a part of this exciting opportunity who offers a competitive salary, excellent benefits package, please email your up-to-date CV to: dariusz.sternlicht@docsglobal.com

#ctajob