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