About the role
Job Description
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 & 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
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 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.
Additional Information
Become a full-fledged clinical research professional with the support of a knowledgeable and professional team. You will develop a variety of skills while progressing with the company and contributing to our full-scale challenging projects.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.