Clinical Study Administrator
Division: Clinical R&D CSS
Onsite
Rate ? 48 Euros/hr ? 65Euros/hr
Location ? Diegem
Duration - 6 Months (possible extension )
Freelance accepted as well = 80% FTE
Overview:
- Provide support to the clinical study staff within Clinical R&D, as well as fostering strong, productive relationships with colleagues within the Clinical R&D 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 + Approx. %
- Clinical study administrative tasks - 85%
- Other Administrative Activities - 15%
Key Job Activities:
- 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 resolve issues relating quickly and effectively to Study Files (Trial Master File and Clinical Study Administrator ? JUL 2019 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 (one)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 (one)CTMS and routing for internal approval)
- Participates in process improvement activities related to (one)CTMS/vTMF within the department.
Experience
- 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).
For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to rurayayi@achieva.co.uk
- Agency: Achieva Group Limited
- Reference: RU-133
Website: Achieva Group Limited
- Posted: 17th March 2023
- Expires: 14th April 2023
