(Junior) Clinical Site Management Associate (NL/EN) Leuven (BE) • Oxford Global Resources

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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 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