Site Management Associate II at Psi Cro — King of Prussia, PA

Start your career in clinical research, streamlining communication, maintaining systems and managing documents.

• 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
• 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)