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3 months ago
Qualitair
Salary: Negotiable
Location: Leeds
Job type: Contract
Contact: Ruby Willard
Category: Admin Jobs

Are you an experienced Clinical Study Administrator? Are you looking to take on a new challenge with a Medical Devices Manufacturer? If so we are looking for individuals just like you!

We have an opportunity for a Clinical Study Administrator to join a leading client of ours, you will be supporting the clinical study staff within the Clinical R&D department. You 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.

This is a contract opportunity for 12 months initially, working 37 hours per week Mon-Fri.

Responsibilities 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 on-going 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 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

Experience, qualifications and skills:

  • 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
  • Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point)
  • Candidate should be able of multi-tasking, a great team player, and have a proactive attitude to work

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

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