The position is responsible for providing clerical,administrative, and technical administrative support to one or more businessunits or clients within Clinical Operations.
Responsible for performing activities in compliance withapplicable Corporate and Clinical Operations Policies, Standard OperatingProcedures and Work Instructions
Assists Clinical Monitoring staff with site managementactivities, including serving as a Sponsor representative for sites on assignedstudies, and communicating with sites to ensure compliance with protocolrequirements, study procedures and relevant guidelines
Creates and assists with maintenance of Trial Master File(TMF) and project files, including participation in file audits
Prepares and maintains site manuals, reference tools andother documents
Maintains, updates, and inputs clinical tracking informationinto databases
Tracks incoming and outgoing clinical and regulatorydocuments and updates for investigator sites, studies, project team, or client
Manages shared mailbox, processes site requests and routescorrespondence appropriately
Coordinates the ordering, packaging, shipping and tracking ofsite supplies and materials
Assists with coordination of team meetings, attends meetingsand prepares accurate meeting minutes and action items
May handle receipt, tracking and disposition of Case ReportForms and Queries
Maintains overall awareness in the field of clinical researchby completing all necessary and assigned training
HighSchool diploma or equivalent
Goodcommunication and interpersonal skills
Abilityto embrace new technologies
Minimal travel up to 25% may berequired
Tasks, duties, and responsibilities as listed in this jobdescription are not exhaustive. The Company, at its sole discretion and with noprior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and / or education will also be considered soqualifications of incumbents may differ from those listed in the JobDescription.
The Company, at its sole discretion, will determine whatconstitutes as equivalent to the qualifications described above.
Further,nothing contained herein should be construed to create an employment contract.Occasionally, required skills / experiences for jobs are expressed in briefterms.
Any language contained herein is intended to fully comply with allobligations imposed by the legislation of each country in which it operates,including the implementation of the EU Equality Directive, in relation to therecruitment and employment of its employees.