CRO
Avance Clinical is a Contract Research Organization which offers specialized services supporting drug development for the pharmaceutical and biotechnology industry.
The Project Associate II (PA II) assists the Project Manager (PM) in planning and executing projects by coordinating staff and processes to deliver projects on time, within budget and with the desired outcomes while ensuring the trial is conducted in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.
Core Responsibilities
Support all aspects of project delivery from study commencement to completion, including:
Organize project system and process set-up during initiation phase of a study.
Draft Kick Off Meeting materials and liaise with all stakeholders to facilitate the meeting.
Draft project plans for review by the Project Manager.
Maintain project information in the Clinical Trial Management System (CTMS), including project milestone tracking.
Accurately track project action items, risks, and issues.
Organize, facilitate, and take minutes for project/study team meetings.
Liaise with cross-functional team members to ensure good communication across each study.
Trial Master File (TMF) document review, metadata update and management.
Facilitate quarterly reviews of the TMF with the PM.
Track vendor invoices, site invoices, and investigator grant payments on assigned projects.
Assists the PM with monthly revenue recognition and forecasting, and reviews customer invoices for project labor and expenses.
Key Performance Indicator (KPI) tracking and reporting to Sponsor.
In-house site and Clinical Research Associate (CRA) contact for tracking, shipping, and maintaining drug/study supplies, query resolution, administrative protocol, and study related questions.