Site Management Associate II

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

Benefits

• Professional development and career success support
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• 4.2
• PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
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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
• Minimum 2 year experience within the clinical research industry, corporate or academic environment where administrative experience and technical skills have been gained
• 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
• Basic typing skills in English (min. 40 words per minute)
• For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future
• Minimum 2 year experience within the clinical research industry, corporate or academic environment where administrative experience and technical skills have been gained.

Required skills

• Clinical Research, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word

Experience

• 2+ years