Lead CRA managing monitoring and site-management services for Alimentiv, a clinical research services company.
Overseeing site activation, recruitment, data quality, regulatory documentation, and CRA mentoring across clinical studies.
Responsibilities
Manage, deliver and/or perform full clinical site monitoring services for one or more projects, potentially involving multiple services, complex studies, and multinational projects
Design and oversee project monitoring services, including training, site/patient recruitment, site data/document management, project site budgets, and regulatory filings aligned with SOPs, study guidelines, and GCP best practices
Act as the primary liaison between CRAs and the project team as Lead CRA
Participate in developing project plans, protocols, CRFs, communications, monitoring forms, documents, and tools
Conduct and document onsite and remote site monitoring, close-out, qualification, and initiation visits
Review study data against source documents, resolve or escalate data queries, and ensure compliance with study requirements
Coordinate shipment and delivery of investigational products, laboratory supplies, ePROs, and study documents
Train site staff on protocols, study plans, systems, and ICH-GCP
Review ISF and TMF for accuracy, timeliness, and completeness; request missing site documents
Serve as primary contact for investigational-site questions and issues
Track site issues, action items, and protocol deviations through resolution
Coordinate site communications and provide project, regulatory, and study updates
Support site activation, regulatory document review/localization/translation, and study start-up
Optimize patient recruitment and help sites meet recruitment milestones
Participate in audits, inspections, study meetings, teleconferences, and Investigator meetings
Mentor and support CRA I and II
Perform CRA assessment visits, co-monitoring visits, and visit sign-off processes
Participate in CRA interviews, process improvement initiatives, and best-practice development
Requirements
Minimum of a college diploma/degree
4–6 years of related experience
Ability to regularly travel to clinical sites
Proficiency with EDC systems such as Medidata Rave and Oracle InForm
Proficiency with IRT, eTMF, CTMS, and Microsoft Office Suite
Ability to travel up to 40–60%, depending on project assignment and site geography
Strong interpersonal and problem-solving skills
Ability to work independently and within cross-functional teams
Market Research Analyst helping Ipsos clients understand brand performance through surveys, data verification, and consumer insights. Supporting recommendations that drive business, brand, and marketing decisions.
Public health policy analyst guiding Peel Region’s family health programs through research, epidemiology, and policy analysis. Developing recommendations, reports, and presentations for population health decisions.
Senior Research Analyst supporting IDC’s global enterprise storage research. Developing market models and insights on storage systems, vendors, technologies, and adoption trends.
Ecommerce catalog analyst researching technology products and managing accurate Magento listings. Auditing product data, updating specifications and pricing, and monitoring competitor marketplaces for Uvation.
Equity Research Associate supporting Desjardins Capital Markets' analyst with financial models, databases, and research reports. Liaising with sales, trading, and firm teams in Montréal.
Lead sustainability research on disaster finance, insurance, and climate resilience for Canada’s applied research organization. Direct applied research projects, stakeholder engagement, business development, and resilience convenings.
Research Associate managing healthcare and pharmaceutical market research projects for MD Analytics. Overseeing fieldwork, data tables, statistical analyses, and report development.
Prospect Research Analyst identifying donors and delivering fundraising insights for the University of Alberta. Conducting risk assessment research and maintaining accurate prospect data.
Research Analyst analyzing real estate markets, fund performance, and investments for Canadian asset manager Centurion. Embedding AI tools into research workflows and producing investor - focused commentary.