Senior Site Operations & Compliance Leader

Psi CRO; Illinois; On-site; USD 65,000 - 90,000; Full time

Job summary

PSI CRO is seeking a Site Management Associate II in the United States, Illinois region to coordinate site activities across trials and vendors. You will manage site records, assist with TMF, training, and audits while supporting cross-functional teams.

The role requires at least a bachelor’s degree and 3+ years in clinical research (CRO preferred), with proficient MS Word/Excel/Outlook/PowerPoint skills and TMF system knowledge.

Qualifications

• College or university degree or equivalent combination that presents the required knowledge, skills and abilities.
• Minimum 3-year experience within the clinical research industry, CRO preferred, in 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 Power Point.
• Knowledge (following proper training) of applicable software and project specific systems.

Responsibilities

• Main site contact for all non-trial-participant related and non-protocol related issues.
• 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.

Education

Bachelor's degree or equivalent in life sciences/related field

Tools

MS Word

MS Excel

MS Outlook

MS PowerPoint

TMF systems

Job description

PSI CRO is seeking a Site Management Associate II in the United States, Illinois region to coordinate site activities across trials and vendors. You will manage site records, assist with TMF, training, and audits while supporting cross-functional teams.

The role requires at least a bachelor’s degree and 3+ years in clinical research (CRO preferred), with proficient MS Word/Excel/Outlook/PowerPoint skills and TMF system knowledge.