OrganizationLocal affiliate of an International Medical Devices Company
Description of the PositionThis individual will 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.
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.
Key Job Activities:
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.
Demands of the PositionEducation
- Minimum of a Bachelor’s Degree is required.
- Previous clinical research experience is a plus.
- Requires previous administrative support experience or equivalent for at least 1 year. - Clinical/medical background is a plus.
- Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point).
- Strong written and verbal communications
- Attention to details
- Strong in organization