Clinical Trials Associate: eTMF & CTMS Coordinator

VitalBio; Oakville; On-site; CAD 55,000 - 70,000; Full time

Job summary

VitalBio seeks a detail-oriented clinical operations professional in Oakville, Ontario, to manage eTMF continuity, regulatory documentation, and study trackers. You will ensure audit-ready files and accurate CTMS input while coordinating with site staff and cross-referencing data across systems.

The role requires 0–2 years in clinical research, strong Excel skills, and familiarity with ICH-GCP. This 12-month onsite contract emphasizes meticulous documentation and effective cross-team

Qualifications

• Bachelor's degree in life sciences or a related field
• 0-2 years in clinical research (IVD, CRO, Pharma, or Biotech preferred)
• Proficiency with eTMF platforms (e.g., Veeva) and advanced Microsoft Excel
• Strong familiarity with ICH-GCP guidelines and essential document workflows
• Experience with EDC tools like Medrio is not required but strongly preferred

Responsibilities

• Maintain the CTMF/eTMF according to ICH-GCP guidelines and company SOPs
• Perform routine reviews of study files and site documents to ensure completeness and accuracy
• Collect and archive essential site regulatory documents (IRB approvals, FDA 1572s, CVs)
• Reconcile documentation gaps prior to audits and study monitoring visits
• Update critical study trackers for patient screening, enrollment, and milestones
• Input accurate operational data into the Clinical Trial Management System (CTMS)
• Generate status reports regularly for Clinical and Regulatory Affairs leaders
• Cross-reference data points across systems to ensure absolute accuracy
• Act as the key contact for routine, non-clinical site administrative queries
• Coordinate study logistics, including distribution of study reagents and other trial materials
• Schedule study meetings, distribute agendas, and publish concise meeting minutes
• Follow up with site staff directly to secure missing administrative paperwork

Skills

eTMF platforms (Veeva)

Microsoft Excel

ICH-GCP guidance

Medrio (EDC)

Education

Bachelor's degree in life sciences or related field

Tools

CTMS

Job description

VitalBio seeks a detail-oriented clinical operations professional in Oakville, Ontario, to manage eTMF continuity, regulatory documentation, and study trackers. You will ensure audit-ready files and accurate CTMS input while coordinating with site staff and cross-referencing data across systems.

The role requires 0–2 years in clinical research, strong Excel skills, and familiarity with ICH-GCP. This 12-month onsite contract emphasizes meticulous documentation and effective cross-team