Job DescriptionThe 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 InformationBecome 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.
