Bilingual Site Management Associate I

Hybrid role in Mississauga ON Canada

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

Other departmental assignments as necessary

Qualifications :

College or university degree or an equivalent combination of education training and experience that presents the required knowledge skills and abilities is considered sufficient. 

Minimum 2 year experience within the clinical research industry corporate or academic environment where administrative experience and technical skills have been gained.

• Basic proficiency in MS Word.
• Basic proficiency in MS Excel.
• Basic proficiency in MS Outlook.
• Basic proficiency in MS Power Point.
• Proficiency in English and French is mandatory.
• Knowledge (following proper training) of applicable software and project specific systems.
• Basic typing skills in English (min. 40 words per minute)

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Full-time