Cardio Health Clinical Trials (CHCT) is a site management organization with over a decade of experience in managing and conducting clinical trials across multiple therapeutic areas, specializing in Cardiovascular and Gastroenterology. With multiple investigator sites across Ontario, CHCT is committed to delivering personalized services with a team of qualified experts.
Position Summary
The Clinical Research Coordinator (CRC) plays a pivotal role in supporting, facilitating, and coordinating the day-to-day clinical trial activities under the direction of the Principal Investigator (PI). The CRC ensures the seamless execution of clinical trials while adhering to Good Clinical Practice (GCP) guidelines and regulatory standards. This role requires close collaboration with the Clinical Trial Manager, study sponsors, and institutional stakeholders.
Key Responsibilities
General Responsibilities
· Conduct clinical research studies in compliance with the study protocol, Good Clinical Practice (GCP), and CHCT Research SOPs.
· Participate in clinical trial activities, including pre-screening, screening, informed consent procedures, randomization, administration, vital signs and ECG recording, visit coordination, sampling, and scheduling.
· Maintain regulatory documentation and study-specific logs.
· Ensure timely and accurate transcription of data into source documents, paper case report forms, and electronic CRFs.
· Proficiently perform phlebotomy and handle biological sample processing.
· Travel to attend research and investigator meetings as required.
· Participate in monitoring visits, investigator meetings, site initiation visits, closeout visits, and audits.
· Manage package drops and pickups (e.g., Amazon, FedEx) to ensure study materials and samples are available and handled promptly.
Participant Engagement
· Recruitment: Identify, screen, and enroll eligible study participants while obtaining informed consent.
· Visit Coordination: Schedule patient visits as per protocol and maintain adherence to study timelines.
· Participant Interaction: Conduct study visits, assess adverse events, monitor safety, and collect biological samples.
Operational Support
· Study Compliance: Maintain accurate, up-to-date study binders and ensure adherence to regulatory requirements.
· Sample Handling: Collect, process, label, store, and ship biological specimens in line with protocol requirements.
· Equipment Oversight and Training:
o Conduct routine checks to ensure research equipment is functional.
o Train and operate trial-specific equipment, including cardiology diagnostic tools and specialized devices.
o Promptly report and address equipment-related issues.
· Package Management: Handle the pickup and delivery of study materials and samples efficiently.
Site Management
· Serve as a backup CRC at other CHCT sites as needed.
· Coordinate with team members to ensure seamless site operations and coverage.
QualificationsEducation
· You must hold a current certification of registration from the College of Nurses of Ontario and maintain membership with the RPNAO or RNAO.
Certifications
· Good Clinical Practice (GCP) certification (essential).
· Certifications from SOCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) are highly preferred.
· Phlebotomy certification is required.
· [NR1] CPR/First Aid certificate an asset
Experience
· 2-3 years of experience in clinical trials, research coordination, or related clinical roles (Phase 1-4 clinical trial experience is an asset).
· Infusion experience (e.g., IV insertion, IV drug administration, infusion monitoring)
· Experience in patient recruitment, informed consent, and patient visit coordination.
· Proficiency in biological sample collection, handling, and processing.
· Experience working in hospital or clinic settings for 2-3 years.
· Familiarity with electronic data capture systems and trial master files (TMFs).
Skills
· Experience in Physical Assessment: Proficient in medical terminology and capable of taking vital signs (BP, RR, temperature, etc.).
· Communication Skills: Excellent verbal and written communication for interactions with patients, sponsors, and research teams.
· Organizational Skills: Strong multitasking ability with exceptional attention to detail and accurate record-keeping.
· Regulatory Knowledge: Familiarity with Health Canada and FDA regulations relevant to clinical trials.
· Technical Proficiency: Competency in clinical trial management systems (CTMS) and MS Office Suite (Word, Excel, PowerPoint).
· Knowledge of IATA Shipping Regulations and Basic Laboratory Procedures: Ensures proper handling and transport of biological samples.
· Flexibility and Teamwork: Capable of working independently with minimal supervision and collaborating within a team environment.
· Problem-Solving and Analytical Skills: Ability to identify and resolve issues effectively.
Other Requirements
· Availability to work beyond standard business hours, including evenings and weekends, if required by the study protocol.
· Ability to travel between research sites when necessary.
· Access to reliable transportation for site visits and package deliveries.
· Adherence to professional appearance and conduct, following a business casual dress code or study-specific guidelines.
CPR/First Aid certificate an asset
Pay: $30.00-$35.00 per hour
Benefits:
- Dental care
- Extended health care
Application question(s):
- Outline your clinical trial experience
- Describe your experience with patient history taking
- 4. Provide examples of your organizational skills
Licence/Certification:
- Registered Nurse License (required)
Willingness to travel:
Work Location: In person
