Clinical Research Associate — Global Site Monitoring

1203 Syneos Health Canada LP; Toronto; Hybrid; CAD 70,000 - 95,000; Full time

Job summary

Syneos Health Canada LP is seeking qualified Clinical Research Associates to support site qualification, initiation, monitoring, and close-out visits across Canada. The role emphasizes regulatory compliance, GCP adherence, and ensuring data integrity through source document reviews and CRF data verification.

Applicants should hold a bachelor’s degree or RN in a related field, possess strong communication and interpersonal skills, and be prepared to travel up to 75%.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; communicates/escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.

Skills

Communication skills

Interpersonal skills

Computer skills

Regulatory knowledge

Travel willingness

Education

Bachelor's degree or RN in related field

Job description

Syneos Health Canada LP is seeking qualified Clinical Research Associates to support site qualification, initiation, monitoring, and close-out visits across Canada. The role emphasizes regulatory compliance, GCP adherence, and ensuring data integrity through source document reviews and CRF data verification.

Applicants should hold a bachelor’s degree or RN in a related field, possess strong communication and interpersonal skills, and be prepared to travel up to 75%.