Requirements: English
Company: Oxford Global Resources
Region: Leuven , Flanders
Are you excited to start your career in Clinical Research? Do you want to be part of a growing, dynamic, global company with a very nice familial team spirit? Don''t hesitate and apply now!
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 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
- 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 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
- 1 year as an Oxford consultant followed by a fixed client contract
Vacancy number: 26018