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 3,200+ driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing current medicines to those who need them.

Job Description
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 CTMSAssists 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.

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.

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📌 Site Management Associate I (Ontario)
🏢 PSI CRO
📍 Ontario