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Clinical Trial Coordinator

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Company :
PSI CRO

Location :
Durham, North Carolina

Expiry Date :
Fri, 06 Nov 2020 23:59:59 GMT

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Description :
Job Description

This is an office-based position in Durham, NC.

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 systemsaudits 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 trainingof 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