Senior Site Management Associate

PSI CRO

11d

About The Position

The Senior Site Management Associate serves as a main contact for non-trial-participant and non-protocol-related site matters, including vendors, trial supplies, and access management. The role supports site and off-site facility records, regulatory and ethics committee documentation, site payments, audits and inspections, query resolution, and review of site-specific EDC progress. It also provides administrative coordination for internal project teams and Investigator Meetings, supports training for investigator site teams, and maintains trial documentation and systems records, including TMF and ISF files. Under supervision, the role provides on-the-job coaching to Site Management Associates I and II and Clinical Operations Administrative Support staff. The position requires at least three years of clinical research industry experience in a similar role or equivalent to Site Management Associate II, with a CRO background preferred. PSI notes that it is not hiring individuals who require a work visa now or in the future.

Requirements

• A college or university degree, or an equivalent combination of education, training, and experience that provides the required knowledge, skills, and abilities.
• At least 3 years of experience in the clinical research industry in a similar role or equivalent to Site Management Associate II.
• Basic proficiency in MS Word, MS Excel, MS Outlook, and MS PowerPoint.
• Knowledge of applicable software and project-specific systems following proper training.

Nice To Haves

• Clinical research experience in a CRO is preferred.

Responsibilities

• Serve as the main site contact for non-trial-participant 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 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.
• Under supervision, provide 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 conduct 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.

Benefits

• Support from a knowledgeable and professional team.
• Opportunity to develop a variety of skills and progress with the company while contributing to challenging projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed