Hybrid role in King of Prussia, PA
Site Management
- Ensures exchange of information and documentation with sites and vendors
- Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
- Ensures regulatory and ethics committee submissions and notifications
- Ensures proper administration of sites and vendors payments
- Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
- Reviews and coordinates site-specific query resolution
- Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status
Other Communication
- Exchanges information and documentation with other departments
- Supports the organization of internal team meetings including preparation of agendas and minutes
- Supports the organization of Investigator Meetings
- Maintains study-specific and corporate tracking systems
- Serves as the sites’ primary contact point
- Serves as the primary sites’ contact point for vendors, study supplies, and access management
- Ensures communication between the sites and off-site facilities
Training
- Arranges and tracks initial and on-going project training for site teams in all vendor-related systems
- Provides training in courier management and study supplies ordering to the site team
Document Management
- Checks the TMF on a site and a country level regularly and files pending documents
- Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
- Provides Monitors with ISF documents to be filed in the ISF prior to each monitoring visit
- Revises and checks translations status
Safety Management
- Ensures proper safety information flow with the investigative sites.
CTMS Management
- Updates CTMS with lacking project information
- Assists the Monitors in their prompt completion of all subject event and site event information in CTMS
- Assists the Monitors in their meeting deadlines for site visits, visit reports and visit letter dates information recording in CTMS
- Tracks the resolution status of site issues and action items in CTMS
Vendor Management
- Ensures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
- Tracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) on a site level