Site Management Associate I

PSI CRO•King of Prussia, PA

13d•Hybrid

About The Position

The Site Management Associate I supports clinical research site management by coordinating information, documentation, supplies, regulatory submissions, payments, training, safety communications, and vendor activities. This is a hybrid role based in King of Prussia, Pennsylvania. The associate serves as a primary contact for sites and coordinates communication between sites, vendors, and off-site facilities. The position also supports monitors with site documentation, query resolution, CTMS updates, and study deadlines.

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 within the clinical research industry or a corporate or academic environment, including administrative experience and technical skills.
Basic proficiency in MS Word, MS Excel, MS Outlook, and MS PowerPoint.
Knowledge of applicable software and project-specific systems following proper training.
Basic English typing skills of at least 40 words per minute.

Responsibilities

Exchange information and documentation with sites, vendors, and other departments.
Coordinate clinical supply orders, 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; provide the site Monitor with regular completion-status updates.
Support internal team meetings, including preparing agendas and minutes, and help organize Investigator Meetings.
Maintain study-specific and corporate tracking systems.
Serve as the primary contact point for sites and for vendors, study supplies, and access management; facilitate communication between sites and off-site facilities.
Arrange and track initial and ongoing project training for site teams in vendor-related systems; train site teams on courier management and study supply ordering.
Check the TMF regularly at site and country level and file pending documents.
Prepare, distribute, and update Investigator Site Files (ISF) and checklists; provide Monitors with ISF documents for filing before monitoring visits.
Review and check translation status.
Ensure proper safety information flow with investigative sites.
Update CTMS with missing project information and assist Monitors with timely completion of subject and site event information, site visit deadlines, visit reports, and visit-letter dates.
Track the resolution status 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.