Bilingual Site Management Associate I

PSI CRO; Mississauga; Hybrid; CAD 70,000 - 90,000; Full time

Job summary

PSI CRO is seeking a Hybrid Site Management professional in Mississauga, ON, Canada. You will ensure information flow with sites and vendors, manage site supplies, and coordinate audits and TMF activities.

You’ll train site teams, manage ISF documents, and support investigator meetings, keeping tracking systems up to date. Role requires a college/university degree, 2+ years in clinical research, and strong English/French skills.

Qualifications

• College or university degree or equivalent in education, training and experience.
• Minimum 2 years' experience in the clinical research industry or equivalent.
• Basic proficiency in MS Word, MS Excel, MS Outlook and MS PowerPoint.
• Proficiency in English and French is mandatory.
• Basic typing skills in English (min. 40 words per minute).
• Knowledge of applicable software and project-specific systems.

Responsibilities

• Ensures exchange of information and documentation with sites and vendors.
• Manages site documentation, inventory and payments administration.
• Coordinates site audits, TMF, and systems inspections.
• Reviews site queries and EDC completion updates for monitors.
• Supports organization of investigator meetings and internal team meetings.
• Maintains study tracking systems and serves as primary contact for sites and vendors.
• Arranges and tracks project training for site teams in vendor systems.
• Maintains ISF and ISF checklists; updates translations status.

Skills

MS Word

MS Excel

MS Outlook

MS PowerPoint

English and French

Typing speed 40 wpm

Education

College or university degree

Job description

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 new 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 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.