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Clinical Trial Assistant - Belgium   This individual will provide support to the clinical study staff within the Clinical R&D COE, as well as fostering strong, productive relationships with colleagues within the Clinical R&D COE organization.

BrightOwl managed [?] Project on hold

Functional titles : Clinical Trial Assistant (CTA) ,  R&D
Project Types : Permanent position ,
FTE : 100 %
Min.Experience : Junior
Start Date : 07 May 2017
End Date : 01 May 2018
Posted on : 03 May 2017

Project is currently here

Step 1
Application
Step 2
BrightOwl Screening
Step 3
BrightOwl Interview
Step 4
Company Screening
Step 5
Company Interview
Step 6
Budgets & Contracts
Step 7
Position filled

Project Description

This individual will provide support to the clinical study staff within the Clinical R&D COE, as well as fostering strong, productive relationships with colleagues within the Clinical R&D COE organization.

Responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required.

Supports project managers within the assigned clinical studies.

Major Responsibilities:

Clinical study administrative tasks 70%

Other Administrative Activities 30%

Others

Project FTE 100%
Work from home:   Not Allowed
No. of Positions:   1

Personality

Attention to detail Communicative Organization

Knowledge

Clinical Data Management Clinical research Administrative support

Skills and Expertise

Administrative support Manage clinical trial files/documents Creation/distribution of regulatory binders Assist study staff and investigators Provide safety documentation Communication Manage Clinical Trial Management System (CTMS) Update Clinical Trials Management System (CTMS)

Degree

Bachelor Master

Field of study

Office Management (Mandatory)

Languages

Dutch
Professional Proficiency
Is a big plus
English
Professional Proficiency
Mandatory

Desired Skills & Experience

Key Job Activities:

Clinical Administration Tasks - (includes CTMS build and tracking, v-TMF build & upload)

  • Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
  • Creation/distribution of regulatory binders & the wet-ink signed documents binder
  • Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions.
  • Assist in providing internal communication of important clinical data and events.
  • Support ongoing use of CTMS by maintaining and tracking relevant activities.
  • Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).

 

Other Administrative Tasks

  • May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
  • May be asked to assist with Device tracking and ordering if required and if applicable.
  • Assistance with logistics for Investigator meetings/expert panel meetings
  • Assistance with distribution of newsletter (create mailing list from CTMS and routing for internal approval)
  • Participates in process improvement activities related to CTMS/v-TMF within the department.