Job description

Requirements

  • Entry level
  • No Education
  • Salary £24,000.00 - £28,000.00 gross per year
  • WEST YORKSHIRE WEST YORKSHIRE

Description

CK Group is recruiting for a Clinical Study Administrator to join a world leading medical device company at their site based in Leeds on a 12 month contract basis.

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. The Clinical Study Administrator will be 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.

Responsibilities include to:
- Under general supervision, be 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.
- Create/distribute 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).
- 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.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Minimum of a Bachelor's Degree is required.
- Previous administrative support experience in a clinical research environment.
- Previous pharmaceutical experience.
- Medical device experience would be preferable.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46058 in all correspondence.

  • recruitment