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Job Details

Clinical Trials Associate - Ukraine

Company: Worldwide Clinical Trials
Location: Kharkov
Reference: VN601
Closing Date: 30 Nov 17
Type: Full Time
Salary (£): Competitive
Benefits: On application

Job Summary:

Worldwide Clinical Trials are looking for a full-time, permanent Clinical Trials Associate based in our Kharkov office!

Requirements:

The Clinical Trials Associate is responsible for ensuring all assigned projects for Clinical Operations are performed timely and accurately while interfacing directly with in-house personnel and field employees. The Clinical Trials Associate develops required tools, forms and documents, and provides additional administrative support for Clinical Operations.

RESPONSIBILITIES:

* Develop and maintain documents, tools, forms and related items in MS Word, Excel, Access and Publisher, including reformatting and troubleshooting issues with existing documents and macros
* Assist Clinical Operations personnel with study initiations and special projects
* Provide technical assistance to project team (Project Managers, Lead CRAs, CRAs, etc.) with forms, letters, reports, manuals and other documents
* Manage document control functions, including maintaining Master List of paper and electronic documents and media generated and distributed
* Audit and resolve issues of redundancy, currency and consistency of documents on shared drive and portals
* Maintain and quality audit to assure most recent revisions of documents are on portals and server
* Assist project team (CRAs, Lead CRAs and Project Managers, etc.) with collation of documentation required for submission to Regulatory Authorities and Ethics Committees administrative support to the preparation of contracts
* Assist with maintenance of trial master file documents as appropriate and needed
* In liaison with the CRAs, manage preparation of documents for grant payments
* Regularly review the status of key documentation in the file for SOP compliance
* Provide support to Clinical Operations Manager on an ad hoc basis.

OTHER SKILLS AND ABILITIES:

* Excellent written and verbal communication skills
* Ability to work independently and as a team member
* Strong interpersonal skills in a fast-paced and rapidly changing environment
* Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
* Ability to handle multiple tasks, including rapid response in generating new documents, forms and tools
* Strong organizational skills, including ability to develop naming conventions and filing architecture
* Advanced skills in MS Office applications including Microsoft Word, Access, Excel, PowerPoint and Publisher.
* Knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements
* Excellent spoken and written English skills as well as fluency of the language of the country of location


REQUIREMENTS:

* Four year college curriculum or university degree
* At least 1.5 years experience in similar role/position
* Skill sets and proven performance equivalent to above

Apply for this job: Clinical Trials Associate - Ukraine

Contact Information:

Address:  Worldwide Clinical Trials
2nd Floor 172 Tottenham Court Road London
W1T 7NS
England
Tel:  0207 121 61 61
Website:  Visit Our Web Site

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