Clinical Trial Coordinator

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

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.