Category

Description

Essential Job Functions
Project Administration - Utilizes designated clinical trial management system to track and process clinical trial information, (e.g., regulatory documents, enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, supplies, Institutional Review Board re-approvals, data queries) in order to provide analysis of information to PM. Processes and tracks vendor invoices, site invoices, and investigator grants payments on assigned projects. Supports assigned PM with initiating requests to Finance Department to generate customer invoices for project labor and expenses. Oversees regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. May conduct secondary review of Essential Regulatory Documents. May coordinate internal TMF quality review activities and may serve as project representative for external TMF audits. Serves as in-house site contact for collection of non-essential regulatory documents, tracking and maintaining drug/study supplies, query resolution, administrative protocol and study related questions. Assists the PM with projection and validation of financial backlog and project realization on assigned projects. Includes review of regular financial reports and analysis of upcoming project events to verify financial forecasts. Assists in the development of Informed Consent Form using project specific knowledge and performs in-house Case Report Form review.
Reporting - Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PM. Assesses and communicates KPIs for associated job tasks to PM with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PM.
Communication - Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. Schedules and attends internal and external team meetings. May lead internal team meetings and portions of external team meetings as directed by assigned PM. Prepares and distributes all meetings minutes for both internal and external meetings. Follows-up with team members on action items from meetings. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans. Prepares for and attends Investigator Meetings, Kick-Off Meetings, Quick Start Camps, and Quality Finish Camps. May serve as PS representative during external systems/process audits
Training- May train new employees assigned to project. May be assigned as a mentor to new project specialists.
Project Leadership - May serve as primary customer contact when PM is out of the office. Seeks input from Project Director for customer support.
Management

Get In Touch