Clinical Trials Administrative Specialist

PSI CRO; Durham (NC); On-site; USD 42,000 - 64,000; Full time

Job summary

PSI CRO is seeking a Clinical Operations Administrative Support to back our global clinical trials team from our Durham, NC office. The role provides essential administrative and operational support to project teams, ensuring efficient studies, accurate documentation, and timely site support throughout the trial lifecycle.

Under supervision, you will assist with meetings, site payments, TMF processes, and collaboration across departments, vendors, and sites.

Qualifications

• College or university science degree or equivalent.
• Equivalency defined as a minimum of 1 year experience in corporate or academic environment with administrative experience and technical skills gained.
• Strong organizational skills with exceptional attention to detail.
• Ability to manage multiple priorities and work effectively in a fast-paced environment.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications.

Responsibilities

• Exchanges project-specific information and documents with other departments, sites and vendors.
• Maintains information in study-specific and corporate tracking systems.
• Supports regulatory submissions and notifications.
• Assists with organization of internal team meetings.
• Coordinates site payments within the project team under supervision.
• Prepares agendas for, and minutes of, internal team meetings under supervision.
• Assists with Investigator Meetings preparation, conduct and follow-up under supervision.
• Assists with clinical supplies ordering, receipt, storage, distribution, return/recall and reconciliation at PSI warehouse or as defined by the project team.
• Assists with TMF and systems audits and inspections preparation and follow-up.
• Maintains TMF files and ISF on site and country levels under supervision.
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists.

Skills

Organizational skills

Attention to detail

Communication skills

Multitasking

Microsoft Office proficiency

Education

College or university science degree

Tools

Microsoft Office

Job description

PSI CRO is seeking a Clinical Operations Administrative Support to back our global clinical trials team from our Durham, NC office. The role provides essential administrative and operational support to project teams, ensuring efficient studies, accurate documentation, and timely site support throughout the trial lifecycle.

Under supervision, you will assist with meetings, site payments, TMF processes, and collaboration across departments, vendors, and sites.