SUMMARY
The position is responsible for providing clerical, administrative, and technical administrative support to one or more business units or clients within Clinical Operations.
JOB RESPONSIBILITIES
? Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
? Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, 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 and other documents
? Maintains, updates, and inputs clinical tracking information into databases
? Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
? Manages shared mailbox, processes site requests and routes correspondence appropriately
? Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
? Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
? May handle receipt, tracking and disposition of Case Report Forms and Queries
? Maintains overall awareness in the field of clinical research by completing all necessary and assigned training
QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)
? Bachelor degree or above
? Good communication and interpersonal skills
? Ability to embrace new technologies
? Minimal travel up to 25% may be required