North York Research Inc.
Affiliated with North York Dermatology Clinic
North York, Toronto, ON
Full-time | On-site | Monday–Friday | 8:00 AM–5:00 PM
About the Position
North York Research Inc. is seeking an experienced Senior Clinical Research Coordinator (Senior CRC) to join our clinical research team.
North York Research Inc. is a clinical research site affiliated with North York Dermatology Clinic, a large multidisciplinary dermatology practice in North York, Toronto. Our research team conducts multiple concurrent industry-sponsored clinical trials, with a strong focus on dermatology as well as selected studies in related therapeutic areas.
This is a hands-on senior coordination position. The successful candidate will independently coordinate clinical trials while also providing guidance, training and support to CRCs and research assistants.
We are looking for someone with strong study ownership, sound judgment and the ability to independently manage complex study-related issues. We are particularly interested in a candidate who has chosen clinical research as a long-term career and is looking for a stable position where they can continue to grow and contribute to an established research team.
Key Responsibilities
- Independently coordinate Phase II–IV industry-sponsored clinical trials from study start-up through close-out
- Manage participant recruitment, screening, informed consent, enrollment, study visits and follow-up
- Maintain accurate, complete and contemporaneous source documentation and study records
- Complete timely EDC data entry and independently resolve data queries
- Prepare for and participate in site initiation, monitoring, audit and close-out visits
- Serve as a primary site contact for sponsors, CROs and monitors for assigned studies
- Identify, document and appropriately escalate protocol deviations and study-related issues through resolution
- Coordinate AE/SAE documentation and reporting and maintain investigational product accountability where applicable
- Assist with REB submissions, amendments and regulatory documentation
- Maintain complete and inspection-ready regulatory and study files
- Train and mentor CRCs and research assistants and provide guidance on complex study-related issues
- Work closely with investigators and research management to maintain compliance with study protocols, ICH-GCP, applicable regulations and site SOPs
Required Qualifications
- 3 or more years of direct, site-level Clinical Research Coordinator experience preferred
- Demonstrated experience independently coordinating multiple industry-sponsored clinical trials
- Strong working knowledge of ICH-GCP and clinical trial processes
- Hands-on experience with participant screening, informed consent, source documentation, EDC and query resolution
- Experience preparing for and participating in sponsor/CRO monitoring visits
- Experience communicating directly with sponsors, CROs and monitors
- Ability to independently manage multiple concurrent studies, competing deadlines and study-related issues
- Strong organizational, documentation and communication skills
- High level of attention to detail, professionalism and sound judgment
Preferred Qualifications
- Previous Senior CRC experience or demonstrated senior-level CRC responsibilities
- Experience training or mentoring CRCs or other research staff
- Experience with Phase II and Phase III pharmaceutical clinical trials
- Dermatology clinical research experience
- Experience with REB submissions and amendments
- Experience with audit or regulatory inspection preparation
- Experience with study start-up and close-out
- Familiarity with major EDC, CTMS and IWRS/IRT platforms
- Health Canada Division 5 and TCPS 2 training
The Person We Are Looking For
The ideal candidate takes ownership of assigned studies, places participant safety and data integrity first, communicates confidently with sponsors and monitors, and can independently identify and manage study-related problems.
You should be comfortable remaining actively involved in day-to-day clinical trial coordination while also providing practical guidance and mentorship to less-experienced research staff.
We are looking for someone who is dependable, punctual and able to consistently begin work at 8:00 AM, as important clinical trial and participant activities take place early in the day.
Most importantly, we are looking for someone interested in building a long-term career in clinical research and becoming a stable and valued member of our research team.
This is a full-time, fully on-site Senior Clinical Research Coordinator position at our North York location, Monday through Friday, 8:00 AM–5:00 PM.
Application question(s):
- 1-Have you independently coordinated multiple industry-sponsored clinical trials as the primary or responsible CRC at an investigative research site? Please answer Yes or No.
- 2. What is the greatest number of active industry-sponsored clinical trials you have personally coordinated concurrently as the responsible CRC? Please answer with one of the following: 1–2, 3–5, 6–10, or more than 10.
- 3. Have you held a Senior CRC position OR regularly performed senior-level responsibilities that included training, mentoring, or providing day-to-day guidance to other CRCs or research staff? Please answer Yes or No.
- 4. Have you regularly served as the primary site contact for sponsors, CROs and monitors AND independently managed study-related issues identified during monitoring visits? Please answer Yes or No.
- 5. Briefly describe the senior-level responsibilities you performed in your most recent CRC position. Please include the approximate number of CRCs/research staff you regularly supported or mentored and the number of active studies you were responsible for. Please limit your response to 3–5 sentences.
- 6. This is a full-time, hands-on Senior CRC position that requires independent study coordination, mentoring and supporting other research staff. The position is fully on-site in North York, Monday through Friday, from 8:00 AM to 5:00 PM, with a reliable 8:00 AM start required. Are you comfortable with these responsibilities, able to consistently work this schedule, and interested in continuing your long-term career in clinical research? Please answer Yes or No.
Experience:
- Clinical research Coordinator: 3 years (preferred)
Work Location: In person
