Site Management Associate I

PSI CRO•Durham, PA

13d•Hybrid

About The Position

The Site Management Associate I supports clinical study site operations by coordinating communications, documentation, supplies, payments, training, safety information, and vendor activities. The role serves as a primary contact for sites and helps ensure study records and systems are current, complete, and ready for audits or inspections. This is a hybrid position in Durham, North Carolina.

Requirements

College or university degree, or an equivalent combination of education, training, and experience demonstrating the required knowledge, skills, and abilities.
At least 2 years of experience in the clinical research industry, a corporate environment, or an academic environment, with administrative experience and technical skills.
Basic proficiency in MS Word, MS Excel, MS Outlook, and MS PowerPoint.
Basic English typing skills of at least 40 words per minute.
Knowledge of applicable software and project-specific systems following appropriate training.

Responsibilities

Exchange information and documentation with sites, vendors, and other departments.
Coordinate clinical supplies, including ordering, receipt, inventory, storage, distribution, returns or recalls, and reconciliation.
Ensure regulatory and ethics committee submissions and notifications are completed.
Ensure proper administration of site and vendor payments.
Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections.
Review and coordinate site-specific query resolution and EDC completion, and provide the site Monitor with regular completion updates.
Serve as the primary contact point for sites and coordinate site communications with vendors, study supplies, access management, and off-site facilities.
Support internal team meetings, including preparing agendas and minutes, and support Investigator Meetings.
Maintain study-specific and corporate tracking systems.
Arrange and track initial and ongoing project training for site teams in vendor-related systems; train site teams in courier management and study-supply ordering.
Regularly check the TMF at site and country level and file pending documents.
Prepare, distribute, and update Investigator Site Files (ISFs) and ISF checklists; provide Monitors with ISF documents for filing before monitoring visits.
Check translation status.
Ensure proper safety information flow with investigative sites.
Update CTMS with missing project information and assist Monitors with recording subject and site events, visit deadlines, visit reports, and visit-letter dates in CTMS.
Track resolution of site issues and action items in CTMS.
Ensure completion of vendor pre-study testing at local site facilities, including dummy scans, MRI/CT qualification questionnaires, and test ECGs.
Track vendor-related supplies at the site level, including lab kits, ECG electrodes, and scan CDs.
Perform other departmental assignments as necessary.