Clinical Research à United States

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800+ driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Hybrid role in Mississauga, ON, Canada

• 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

• 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 primary contact point for sites
• Serves as the primary contact point for vendors, study supplies, and access management
• Ensures communication between the sites and off-site facilities

• Arranges and tracks initial and ongoing project training for site teams in all vendor-related systems
• Provides training in courier management and study supplies ordering to the site team

• Checks the TMF regularly at site and country levels 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 translation statuses

• Ensures proper safety information flow with investigative sites

• Updates CTMS with missing project information
• Assists Monitors in their prompt completion of subject and site event information in CTMS
• Helps meet deadlines for site visits, reports, and visit letters in CTMS
• Tracks resolution status of site issues and action items in CTMS

• Ensures completion of pre-study testing of local site facilities (dummy scans, MRI/CT questionnaires, test ECGs, etc.)
• Tracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) at the site level

College or university degree or equivalent education, training, and experience that demonstrate the required knowledge, skills, and abilities are sufficient.

Minimum 2 years of experience in the clinical research industry, in a corporate or academic environment, with administrative and technical skills.

• Basic proficiency in MS Word, Excel, Outlook, and PowerPoint
• Knowledge (following proper training) of applicable software and project-specific systems
• Basic typing skills in English (minimum 40 words per minute)

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