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Bilingual Site Management Associate IPSI CRO • Mississauga, Ontario, Canada
Bilingual Site Management Associate I

Bilingual Site Management Associate I

PSI CRO • Mississauga, Ontario, Canada
2 days ago
Job type
  • Full-time
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.


Remote Work :

No


Employment Type :

Full-time


Experience: years
Vacancy: 1
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Bilingual Site Management Associate I • Mississauga, Ontario, Canada

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