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Clinical Research Coordinator

North York Research Inc.
North York, ON

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Détails du poste

Temps plein
Il y a 2 jours

Compétences

Audit financier
Phlébotomie
Expérience en laboratoire
Pas d'expérience requise
Google Cloud Platform
Microsoft Office
Saisie de données

Description complète du poste

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

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