Clinical Trials Associate (12-month contract)

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

Job summary

VitalBio is seeking a detail-oriented clinical operations professional to manage CTMF/eTMF assets in line with ICH-GCP guidelines. The role involves auditing study files, collecting essential regulatory documents, and maintaining accurate trackers and CTMS data.

Ideal candidates have 0–2 years in clinical research, proficiency with eTMF (Veeva), strong Excel skills, and familiarity with ICH-GCP workflows. This onsite 12-month contract offers exposure to Preclinical and Clinical trials at

Qualifications

• Bachelor's degree in life sciences or related field.
• 0–2 years in clinical research (IVD, CRO, Pharma, or Biotech preferred).
• Proficiency in 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 the 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

Advanced Excel

ICH-GCP

Education

Bachelor's degree in life sciences

Tools

Medrio

Job description

About you:

You are a detail-oriented life sciences professional early in your clinical research career, ready to take on a Clinical Operations role as VitalBio advances into Preclinical and Clinical trials. You have a strong grasp of ICH-GCP guidelines and essential document workflows, and you're comfortable keeping complex studies organized and audit-ready. You're a clear communicator who can act as a reliable point of contact for site staff while cross-referencing data across systems with precision.

About you:

You are a detail-oriented life sciences professional early in your clinical research career, ready to take on a Clinical Operations role as VitalBio advances into Preclinical and Clinical trials. You have a strong grasp of ICH-GCP guidelines and essential document workflows, and you're comfortable keeping complex studies organized and audit-ready. You're a clear communicator who can act as a reliable point of contact for site staff while cross-referencing data across systems with precision.

What you'll do:

• 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 the 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.

What you'll need:

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

The compensation range for this role is $55,000 - $70,000 CAD. Final compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.

This role is a 12-month contract, onsite vacancy.

About VitalBio

Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance.

As part of our recruitment process, we may use automated or AI-supported tools to assist with application review and screening. These tools are used to support, not replace, human decision-making. Final hiring decisions are always made by our hiring team.