Clinical Trial Coordinator
- King of Prussia, PA, USA
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.
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
- 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
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.
All your information will be kept confidential according to EEO guidelines.