Senior Site Management Associate

PSI CRO•US, US

12d

About The Position

The Senior Site Management Associate supports clinical research projects by coordinating administrative, regulatory, records, vendor, and site-management activities. The role serves as a main contact for sites and vendors on non-trial-participant and non-protocol issues, and supports communications between investigator sites, project teams, monitors, and other company departments. The associate prepares and manages regulatory and ethics committee documents, site and trial records, Investigator Site Files, and Trial Master File materials; coordinates site payments, training, translations, audits, inspections, query resolution, and EDC progress tracking; and helps organize Investigator Meetings and internal project team meetings. Under supervision, the role also provides on-the-job coaching to junior Site Management Associates and Clinical Operations Administrative Support staff.

Requirements

College or university degree, or an equivalent combination of education, training, and experience sufficient to demonstrate the required knowledge, skills, and abilities.
At least 3 years of experience in the clinical research industry, preferably at a CRO, in a similar role or equivalent to Site Management Associate II.
Basic proficiency in MS Word.
Basic proficiency in MS Excel.
Basic proficiency in MS Outlook.
Basic proficiency in MS PowerPoint.
Knowledge of applicable software and project-specific systems following proper training.
Must not require a work visa for employment or continued employment now or at any time in the future.

Nice To Haves

Clinical research experience at a CRO is preferred.

Responsibilities

Serve as the main site contact for non-trial-participant-related and non-protocol-related issues, including vendors, trial supplies, and access management.
Manage records flow with sites and off-site facilities.
Prepare regulatory and ethics committee submission and notification documents and records.
Coordinate payments to sites and off-site facilities.
Prepare for and follow up on site audits and inspections.
Review and coordinate site-specific query resolution with monitors and sites.
Review site-specific EDC completion progress and provide regular updates to the Monitor.
Serve as the main contact point for other company departments on administrative site-related issues.
Organize and participate in internal project team meetings and prepare meeting reports.
Collaborate with sites and the project team to organize Investigator Meetings.
Provide, under supervision, on-the-job coaching to Site Management Associates I and II and Clinical Operations Administrative Support staff.
Arrange and track initial and ongoing trial training for investigator site teams in vendor-related systems.
Train investigator sites in courier management and trial supplies ordering.
File trial records in the TMF and perform regular TMF checks at site and country levels.
Participate in and follow up on TMF and systems audits.
Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
Coordinate translation of trial records at site and country levels.
Collect IP-REDs and compile IP-RED packages for further review.
Serve as the main vendor contact for non-trial-participant-related issues, including pre-trial testing of vendor systems.
Track vendor-related supplies at site and country/regional levels.
Exchange information and records with vendors.