CTA - Leeds

20,000 - 30,000
14 Jan 2019
11 Feb 2019
Part Time
Contract Type
Russell Oakley at CK Clinical is recruiting for a CTA to join a Pharmaceutical company in the North of England at their site based in Leeds on a fixed term contract basis.

The Company:
Our client is a biotechnology company in the medical devices sector. They specialise in the production of replacement orthopaedic joints and sockets in the human body and this role will sit within the clinical operations team where you will be directly involved in the associated trials for these products.

The Location: Leeds, West Yorkshire.

The Role:
The main purpose of the role will be to
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.

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.
Support project managers within the assigned clinical studies.
Further responsibilities will include:
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.

Your Background:
Minimum of a Bachelor's Degree is required.
Previous clinical research experience a plus.
Requires previous administrative support experience or equivalent for at least 1 year.
Clinical/medical background a plus. 

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 44374 in all correspondence.

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