Clinical Research Associate jobs

Company Overview

North York Research Inc. is the high-volume Clinical Research Division of North York Dermatology Clinic.

We conduct Phase II–IV clinical trials across multiple dermatologic conditions, including atopic dermatitis, psoriasis, vitiligo, chronic hand eczema, acne vulgaris, prurigo nodularis, lichen simplex chronicus, urticaria, discoid lupus erythematosus, and hidradenitis suppurativa.

Our site operates in a fast-paced, multi-study environment, supporting leading pharmaceutical sponsors and CROs.

Role Overview

This is a hands-on, operational Clinical Research Coordinator role.

We are seeking an experienced CRC who can independently coordinate active dermatology clinical trials within a regulated Canadian clinical research environment.

The successful candidate must demonstrate:

• True study ownership
• Experience managing active clinical trials independently
• Familiarity with Canadian REB processes
• Strong working knowledge of GCP
• Ability to manage real-world site operations, competing priorities, and sponsor/CRO expectations

This role is intended for individuals seeking long-term CRC-level responsibility. We are particularly interested in candidates seeking long-term growth and continued development within site-level clinical research operations.

Work Schedule

• Full-time, on-site position
• Core clinic hours: 8:00 AM – 5:00 PM
• Flexibility required based on patient visits, monitoring visits, sponsor requests, and study needs

Key Responsibilities

Study Coordination & Ownership

• Independently coordinate dermatology clinical trials from start-up through close-out
• Ensure protocol adherence, visit execution, and inspection-ready documentation
• Serve as a primary site contact for sponsors, CROs, CRAs, and monitors
• Prepare for, host, and follow up on monitoring visits, remote reviews, audits, and close-out visits
• Track study progress, outstanding action items, visit windows, and sponsor deliverables

Regulatory & Ethics Oversight

• Manage REB submissions, amendments, renewals, safety submissions, and correspondence
• Maintain complete and inspection-ready regulatory binders and site files
• Maintain accurate delegation documentation and training records
• Ensure informed consent is obtained, documented, and maintained according to REB-approved procedures
• Identify, document, and escalate protocol deviations as required

Data & Systems Management

• Complete timely and accurate data entry in EDC systems
• Resolve queries independently and within sponsor/CRO timelines
• Maintain accurate study tracking in CTMS and internal site trackers
• Follow up with sponsors, CROs, and monitors on outstanding data, regulatory, and operational items

Clinical & Laboratory Oversight

• Coordinate participant visits and subject flow
• Ensure study assessments are completed according to protocol requirements
• Oversee lab processing, shipment, documentation, and issue resolution
• Maintain chain of custody, temperature logs, sample tracking, and lab-related source documentation
• Identify and escalate lab, visit, or documentation issues promptly

Team & Site Collaboration

• Provide guidance and oversight to Research Assistants involved in study activities
• Communicate clearly with investigators, site staff, sponsors, CROs, and monitors
• Escalate operational, compliance, or patient-related concerns appropriately
• Contribute to workflow improvement, site quality, and inspection readiness

Required Qualifications

Applicants must demonstrate:

• Minimum 1 year of hands-on Clinical Research Coordinator experience in regulated clinical trials. Candidates should be capable of independently managing core CRC responsibilities.
• Experience coordinating regulated clinical trials in Canada
• Familiarity with Canadian REB processes
• Strong working knowledge of GCP
• Independent ownership of:
• Study conduct and visit execution
• Monitoring visit preparation and follow-up
• Protocol deviation identification and documentation
• EDC data entry and query resolution
• CTMS or study tracking systems
• Regulatory binder/site file maintenance
• Strong attention to detail, accountability, follow-through, and operational judgment
• Proficiency with Microsoft Office and/or Google Workspace

Preferred Qualifications

• Direct dermatology clinical trial experience
• Experience with Phase II–IV studies
• Phlebotomy experience
• Lab processing and sample shipment experience
• Audit, inspection, or monitoring visit exposure
• Interest in continued growth within CRC-level clinical trial operations

Role Structure

• Reports to: Clinical Research Supervisor and Investigator / Research Director
• Autonomy: High; expected to manage assigned studies independently
• Pace: Fast-paced, structured, accountability-driven, multi-study environment
• Growth: Expanded study ownership based on demonstrated performance

Application Instructions

Resume only.

Applications that do not demonstrate independent CRC-level experience in regulated clinical trials will not be considered.

Pay: From $23.00 per hour

Application question(s):

• Q1. Independent CRC Role

Have you functioned independently as the primary Clinical Research Coordinator on at least one study?
☐ Yes
☐ No

• Q2. CRC Experience

How long have you worked specifically as a Clinical Research Coordinator in Canada?
☐ Less than 1 year
☐ 1–2 years
☐ 3–4 years
☐ 5+ years

• Q3. REB & Ethics Responsibility

Which best describes your experience with Canadian REB/ethics submissions?
☐ Independently managed submissions and amendments
☐ Assisted under supervision
☐ No experience

• Q4. Informed Consent

What was your level of involvement in informed consent?
☐ Independently conducted and documented consent
☐ Assisted under supervision
☐ No involvement

• Q5. Study Load Responsibility

At your previous site, how many studies were you actively coordinating at the same time as the primary CRC?
☐ 1–2
☐ 3–5
☐ 6–8
☐ 8+

• Q6. Monitoring Visits

Which best describes your role during monitoring visits?
☐ I prepare independently, host visits, and complete follow-up
☐ I assist another coordinator
☐ I do not participate

• Q7. EDC Responsibility

Which best describes your EDC experience?
☐ Independent data entry, query resolution, and review
☐ Data entry only
☐ No EDC experience

• Q8. Dermatology Trials

What is your experience with dermatology clinical trials?
☐ Independently coordinated dermatology trials
☐ Assisted only
☐ No dermatology experience

• Q9. Clinical Skills

Which of the following have you performed in a clinical research setting? (Select all that apply)
☐ Phlebotomy
☐ ECG acquisition
☐ Vitals collection
☐ None of the above

• Q10. Visit & Workflow Volume

On a typical clinic day, how many patient visits were you directly responsible for managing?
☐ 1–3
☐ 4–6
☐ 7–10
☐ 10+

• Q11. SMO Experience (Asset)

Have you worked with or at a Site Management Organization (e.g., Probity Medical Research)?
☐ Yes
☐ No

• Q12. Availability

What is your earliest available start date?
☐ Immediately
☐ Within 2 weeks
☐ Within 1 month
☐ More than 1 month

• Q13. Delegation & RA Oversight

Have you worked with Research Assistants supporting your studies (e.g., lab prep, scheduling, source prep)?
☐ Yes — I delegated and reviewed their work
☐ Yes — but I did not oversee them
☐ No

• Q14. Protocol Deviation Handling

When a protocol deviation occurs, what has been your typical role?
☐ I identify, document, and follow through to resolution
☐ I report to someone else to manage
☐ I have not handled deviations

Work Location: In person