Clinical Study Administrator
il y a 3 semaines
You will 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. % of Time Required
Clinical study administrative tasks 85%
Other Administrative Activities 15%
key responsibilities
Clinical Administration Tasks - (includes (one)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 (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. Other Administrative Tasks May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leadersqualifications 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 a plus. Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point). Demonstrated competencies in the following areas are required: Tracking Written and verbal communications Attention to details Organizational skills
key benefits You can fill this position through Randstad Professionals as a consultant In return for your performance and flexibility, we offer you a salary package with some interesting extras, such as Gross salary according to your experience Lunch vouchers of €7 per day worked Net remuneration of €80 per month Company car with fuel card (subject to conditions) or Mileage allowance Hospitalisation insurance 1 extra day's holiday per month worked End of year bonus Pension Plan ECO vouchers worth €250 (on an annual basis, pro rata) Training opportunities
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