PPD, part of Thermo Fisher Scentific

PPD, part of the clinical development services division of Thermo Fisher Scientific, is a leading global contract research organisation (CRO). We provide comprehensive, integrated drug development, laboratory  and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organisations. PPD has conducted clinical trials in more than 100 countries to help customers deliver life-changing therapies to improve health. Using innovative technologies, therapeutic expertise and a firm commitment to quality, we help clients and partners bend the cost and time curve of drug development. PPD Australia’s head office is based in Melbourne, Victoria.

Clinical Trial Coordinator (CTC) Position Description

Clinical Monitoring, Clinical Operations

In Clinical Monitoring, PPD combines institutional knowledge, in-depth therapeutic experience, and robust operational tools to help clients define and develop clinical programs, minimise delays, and execute high-quality, cost-efficient clinical studies. We provide clients with the support and information they need to succeed in the global environment. Dedicated teams of professionals provide consistent and effective monitoring and interaction with study sites.

CTC Purpose:

• Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring essential documents are collected and filed appropriately.

CTC Essential Functions:

• Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.

• Supports the maintenance of study specific documentation and systems including : study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans.

• Performs administrative tasks on assigned trials including  timely upload  of documents to the appropriate  filing systems,  performing mass mailings and communications, providing documents and reports to internal team members.

• Provides system support.

• Supports scheduling of client and/or internal meetings.

• Reviews and tracks local regulatory documents.

• Transmits documents to client and centralised IRB/IEC.

• Analyses and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.

• Maintains vendor trackers.

• Assists with coordination, compilation and distribution of study folders and non-clinical study supplies to sites.

• Actively participate and drive social committee events.

2 placements available