Clinical Trial Coordinator

  • King of Prussia, PA, USA
  • Full-time

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 an office-based position in King of Prussia, PA.

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

All your information will be kept confidential according to EEO guidelines.

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