Clinical Site Operations Specialist II

PSI CRO; Durham (NC); On-site; USD 52,000 - 76,000; Full time

Job summary

PSI CRO is seeking a Site Management Associate to support regulatory submissions, TMF maintenance, and site coordination in a fast-paced clinical research environment. The role requires collaboration with sites and internal teams to ensure efficient project execution.

You'll manage document flow, site payments, audits, and training, while developing skills in investigator meetings and vendor coordination. This position is based in Durham, NC with on-site responsibilities.

Qualifications

• College or university degree or an equivalent combination of education, training and experience
• Minimum 2 years experience within the clinical research industry or related admin environment
• 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
• Basic typing skills in English (min. 40 words per minute)

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 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

Skills

MS Word

MS Excel

MS Outlook

MS PowerPoint

Typing 40 wpm

Software/Project systems knowledge

Education

Bachelor's degree or equivalent

Tools

TMF/ISF systems

Job description

PSI CRO is seeking a Site Management Associate to support regulatory submissions, TMF maintenance, and site coordination in a fast-paced clinical research environment. The role requires collaboration with sites and internal teams to ensure efficient project execution.

You'll manage document flow, site payments, audits, and training, while developing skills in investigator meetings and vendor coordination. This position is based in Durham, NC with on-site responsibilities.