Senior Site Operations Lead – Clinical Trials

PSI CRO; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

PSI CRO is seeking a Site Management Associate II to support trial management activities across sites and vendors. The role focuses on document control, TMF compliance, site training, and coordinating investigator meetings.

Under supervision, you will mentor junior staff, manage ISF packages, and collaborate with project teams to ensure regulatory and quality standards are met globally.

Qualifications

• College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.

Responsibilities

• Main site contact for all non-trial-participant related and non-protocol related issues, including vendors, trial supplies and access management
• Manages records flow with sites and off-site facilities
• Prepares regulatory and ethics committee submission/ notification documents and records
• Coordinates payments to sites and off-site facilities
• Prepares for and follows up on site audits and inspections
• Reviews and coordinates site-specific query resolution with Monitors and sites
• Reviews site-specific EDC completion progress and provides the Monitor with regular updates
• Serves as the main contact point for other company departments in administrative site-related issues
• Organizes, participates in, and prepares reports of internal project team meetings
• Collaborates with sites and project team on Investigator Meetings' organization
• Under supervision, provides on-the-job coaching of Site Management Associates I & II and Clinical Operations Administrative Support staff
• Arranges and tracks initial and ongoing trial training for investigator site teams in all vendor-related systems
• Provides training in courier management and trial supplies ordering to the investigator sites
• Files trial records in the TMF and performs regular TMF checks on a site and country level
• Participates in and follows up on TMF and systems audits
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
• Coordinates the translation process for trial records on a site and country level
• Collects IP-REDs and compiles IP-RED packages for further review
• Main vendor contact for all non-trial participant related issues, including pre-trial testing of vendor systems
• Tracks vendor-related supplies on a site, country/regional level
• Exchanges information and records with vendors

Skills

MS Word

MS Excel

MS Outlook

MS PowerPoint

Project systems knowledge

Education

Bachelor’s degree or equivalent

Tools

Regulatory software

Job description

PSI CRO is seeking a Site Management Associate II to support trial management activities across sites and vendors. The role focuses on document control, TMF compliance, site training, and coordinating investigator meetings.

Under supervision, you will mentor junior staff, manage ISF packages, and collaborate with project teams to ensure regulatory and quality standards are met globally.