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Clinical Study Admin

  • Job reference: 923014
  • Location: Leeds, West Yorkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 12/12/2018

Orion Group are recruiting for a Clinical Study Administrator on behalf of our Multinational Medical Device Client on an initial 12 month contract based in the West Yorkshire Area

This individual will provide support to the clinical study staff within the Clinical R&D COE

Responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects.

Main Responsibilities of the role:

  • Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies.
  • 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).

Education

  • Minimum of a Bachelor's Degree is required.

Experience

  • Previous clinical research experience a plus.
  • Requires previous administrative support experience or equivalent for at least 1 year.
  • Clinical/medical background a plus.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.