Site Management Associate I

Clinical Trial Assistant

Company: PSI
Location: Durham, NC (Hybrid)

Company Overview:
PSI is a dynamic, global company founded in 1995, comprising over 2,800 dedicated professionals. We operate at the forefront of medical science, committed to changing lives by bringing new medicines to those in need.

About the Role:
This hybrid role in Durham, NC, requires a Clinical Trial Assistant to manage site operations, communication, training, document management, safety information flow, CTMS updates, and vendor interactions. You will ensure the smooth execution of clinical trials by serving as the primary contact point for sites and vendors, coordinating information exchange, and maintaining study documentation and supplies.

Site Management:

• Ensure information and documentation exchange with sites and vendors.
• Manage inventory, storage, distribution, and reconciliation of clinical supplies.
• Handle regulatory and ethics committee submissions and notifications.
• Oversee site and vendor payments.
• Coordinate audit preparation and follow-up.
• Review and coordinate site-specific query resolution and EDC completion.

Other Communication:

• Exchange information and documentation with other departments.
• Support the organization of internal team meetings and Investigator Meetings.
• Maintain study-specific and corporate tracking systems.
• Serve as the primary contact point for sites, vendors, study supplies, and access management.
• Ensure communication between sites and off-site facilities.

Training:

• Arrange and track project training for site teams on vendor systems.
• Provide training on courier management and study supplies ordering.

Document Management:

• Regularly check the TMF and file pending documents.
• Prepare, distribute, and update Investigator Site Files (ISF) and checklists.
• Provide Monitors with ISF documents prior to monitoring visits.
• Review and check translation status.

Safety Management:

• Ensure proper safety information flow with investigative sites.

CTMS Management:

• Update CTMS with project information.
• Assist Monitors with prompt completion of subject event and site event information in CTMS.
• Assist Monitors with meeting deadlines for site visits, reports, and visit letter dates in CTMS.
• Track the resolution status of site issues and action items in CTMS.

Vendor Management:

• Ensure pre-study testing of local site facilities is completed.
• Track vendor-related supplies on a site level.

Qualifications:

• College or university degree or an equivalent combination of education, training, and experience.
• Minimum 2 years of experience within the clinical research industry, corporate, or academic environment.
• Basic proficiency in MS Word, Excel, Outlook, and PowerPoint.
• Knowledge of applicable software and project-specific systems (following training).
• Basic typing skills in English (min. 40 words per minute).

Work Authorization:
PSI is not hiring individuals who require work visas for employment or continued employment now or anytime in the future.

Confidentiality:
All information will be kept confidential according to EEO guidelines.