Johnson & Johnson
Clinical Administrator - Remote
Clinical Study Administrator
Franchise Clinical Operations
Located: Remote (looking for candidates in the NW ideally though as there may be travel to site occasionally)
Contract Length: 12 months with possibility of extension
£12-17 per hour PAYE
The role consists of providing support to the clinical study staff within the Medical Device Group, as well as fostering strong, productive relationships with colleagues within the Medical Device Group 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.
- 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).
- 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.
- Bachelor’s Degree is required.
- Requires previous administrative support experience or equivalent for at least 1 year.
- 1+ years experience in Clinical/Medical Administration.
- Requires experience and knowledge working with computer systems (Microsoft Office – Excel, Word and PowerPoint).
- VTMF experience
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job/classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.