Site Management Associate II

PSI CRO•King of Prussia, PA

About The Position

Start your career in clinical research, streamlining communication, maintaining systems and managing documents. The scope of responsibilities will include: 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.

Requirements

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)

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