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March

Clinical Trial Coordinator

PSI Cro - Sydney, NSW

Administration & Secretarial
Source: uWorkin

Source: uWorkin

JOB DESCRIPTION

  • Sydney NSW, Australia
  • Contract
Company Description

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

This is a 12-month contract based in Sydney, Australia

1. Site Management
  • Supervises and coordinates the exchange of data, documents and other project relevant information between investigative sites, the project team, the sponsor, and central / regional vendors
  • Coordinates the process of IRB/IEC and CA submissions and notifications
  • May coordinate financial and contractual tasks
  • Coordinates and assists with preparation and follow-up of site, and systems audits and inspections
2. Other Communication
  • Exchanges data, documents, and other information with the project team, other departments, vendors and customers
  • Coordinates and supervises communication within the project team
  • Coordinates and assists with organization of project meetings
  • Prepares draft agendas for, and minutes of, project meetings
  • Coordinates preparation, attendance and follow-up of Investigators´ Meetings
3. Training
  • Conducts on-the-job coaching of Clinical Trial Administrators
  • Coordinates, conducts and monitors compliance of project-specific training of the study team members
4. Document Management
  • Maintains Trial Master File (TMF)
  • Performs regular TMF QC for completeness and accuracy, and prepares TMF checklists
  • Assists in preparation and follow-up of TMF audits
  • Coordinates preparation, distribution, and update of Onsite Study Files (OSF) and OSF checklists
  • Supervises and coordinates translations
5. Safety Management
  • Coordinates the safety information flow within the project team, and between the project team and investigative sites
6. Compliance Monitoring
  • May perform IP-Release Enabling Document QCs
  • Participate in establishing and supervising in-process controls
7. Project Management
  • May administratively coordinate clinical supplies (including medication) order, receipt, inventory store, distribution, return/recall and reconciliation
  • Assists with preparing draft newsletters, progress reports and project plans
  • Reviews, coordinates and maintains study-specific and corporate tracking systems
  • May be assigned other project management tasks
8. Project Assignments
  • May be assigned a Project Coordinator role within a project
9. Corporate/Departmental Assignments
  • Provides administrative assistance with feasibility research
  • May be involved in the development of practices and training initiatives related to project administration at a regional level
Qualifications

College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.

Minimum 12 months´ experience as a Senior Clinical Trial Administrator or a similar position in clinical research.

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve. Applications from Aboriginal and Torres Strait Islanders are encouraged.

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