Job Description
As a Site Management Associate you will be performing non-monitoring site management activities, providing project administrative support, managing documents, project-specific trackers and maintaining communication with the sites, study vendors and members of the project team. You will be operating at site and country level.
Responsibilities
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 system's 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
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
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
Safety Management
* Ensures proper safety information flow with investigative sites
Other departmental assignments, as necessary
Requirements
* College or University Degree or an equivalent combination of education, training and experience
* A first internship or working experience in the industry or in clinical research is a strong asset
* Full working proficiency in Dutch and English
* Basic knowledge of French
* PC skills to be able to work with MS Word, Excel and PowerPoint
* Ability to plan, multitask and work in a dynamic team environment
* Excellent communication and collaboration skills
Benefits
* Salary package based on experience
* Hybrid policy : 2 days in the office in Leuven, 3 days homeworking