Site Management Associate I

Monitoring & Site Management Etobicoke, Ontario


Description

The Site Management Associate (SMA) will provide centralized, administrative and technical support to the project team(s) and Investigator Sites. The SMA is a critical member of the Clinical Operations team at large, offering continuity and serving as a liaison across departments and project teams. 

The SMA is a pivotal point of contact between the Investigator Site and the project team, ensuring effective and efficient delivery of Site Activation through to Site Close Out in accordance with applicable Veristat Policies, Standard Operating Procedures (SOPs), conventions and instructions set out by the Project Director or Project Manager, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and applicable local regulations.  S/he maintains a constant line of communication with the CRA and other cross functional departments to ensure site activities are compliant with ICH-GCP and approved Project Plans.


As an SMA You Will...

  • Manage all study start up activities with the investigator site, including management of regulatory and ethics document submissions, informed consents, any other trial related material to confirm sites have received full Sponsor and Regulatory approval prior to scheduling the Site Initiation Visit (SIV)
  • Manage site recruitment and retention activity, and report trends or issues with project team in an effective, timely manner
  • Assist with development and production of study materials, essential documents, presentations, reports, submissions, articles, and other materials according to Sponsor needs
  • Prepare index for site master file (SMF), track and file routine clinical study documents, either generated internally by Veristat or received from clients and or investigator sites, including status or subject trackers, subject screening logs and other documents as appropriate
  • Create and maintain site management activities & documents including study and site contact lists, enrollment tracking, regulatory document tracking, including start up documents and other relevant site information within the Clinical Trial Management System (CTMS)
  • Assist Project Director/Manager with site selection and feasibility to include tracking CDAs and feasibility questionnaires, reviewing feasibility documentation, and work with potential sites to prepare for the site qualification visits (SQV)
  • Prepare site status updates at each internal and external project team meeting
  • Assist in preparation for sponsor and/or regulatory audits
  • Perform other duties as required to interface with clients, study vendors and investigative sites to ensure successful trial conduct
  • Provide appropriate administrative support, version control, and document tracking for SOPs, other documents maintained within Clinical Operations
  • As needed, record details of clinical trial shipments and collaborate with others to ensure adequate supplies of clinical trial material are available to meet project needs
  • Assist members of the project team with the preparation for the Investigator Meeting and/or Site Initiation Visit
  • Obtain and disseminate schedules and calendars; prepare and distribute agendas and minutes for internal project team meetings and client meetings
  • Prioritize and resolve time management obstacles
  • Propose new processes, ideas, and enhancements to improve efficiency and accuracy of work
  • Responsible for Trial Master File Maintenance (paper/Electronic Trial Master File (eTMF) and Clinical Document Control for assigned Site

 

Experience + Requirements

  • Bachelor’s degree in a relevant field preferred
  • 2 years in Clinical Operations or similar department required
  • SOCRA or ACRP certification and/or membership preferred
  • Excellent communication skills and attention to detail within a fast-paced office environment required
  • Ability to self-motivate, multi-task and be highly flexible
  • Willing and able to work well in a matrixed environment, across departments, across levels, amongst competing priorities and multiple stakeholders (both internally and externally)
  • Expert skills in Microsoft Word, Excel, Project, and PowerPoint required