Job Description

40hours a week 12 month contract on a T4. Position is on site 5 days a week

A Clinical Site Manager with a nursing qualification in Canada typically oversees clinical trials, ensuring that research sites comply with regulations and study protocols. Their role combines clinical expertise with project management and regulatory compliance.

Job Description: Clinical Site Manager (Nursing Background)

Job Overview:

The Clinical Site Manager (CSM) is responsible for managing clinical trial sites, ensuring compliance with regulatory requirements, overseeing study protocols, and coordinating with healthcare professionals and sponsors. They play a crucial role in monitoring patient safety, data integrity, and site performance.

Key Responsibilities:

1. Site Management & Oversight

• Act as the primary liaison between the sponsor, contract research organization (CRO), and the clinical site.
• Ensure that clinical trials are conducted according to Good Clinical Practice (GCP), regulatory guidelines, and company SOPs.
• Conduct site visits for monitoring, risk assessment, and compliance verification.
• Resolve issues related to site performance, recruitment, and protocol adherence.

2. Patient Safety & Compliance

• Ensure patient safety and rights are protected throughout the study.
• Oversee informed consent procedures and adherence to ethical guidelines.
• Ensure accurate reporting of adverse events (AEs) and serious adverse events (SAEs).

3. Regulatory & Documentation Compliance

• Ensure all site documentation (including ethics approvals and investigator site files) is complete and up-to-date.
• Maintain compliance with Health Canada regulations, FDA (if applicable), and ICH-GCP guidelines.
• Assist in preparing sites for audits and inspections.

4. Study Coordination & Training

• Train site staff on study protocols, procedures, and documentation requirements.
• Support and troubleshoot challenges related to patient recruitment and data collection.
• Conduct investigator meetings and regular check-ins with site personnel.

5. Data Management & Reporting

• Ensure timely and accurate data collection, entry, and reporting.
• Monitor data quality and address discrepancies.
• Collaborate with data management teams to resolve issues in real time.

Required Qualifications & Skills:

Education & Experience

• Nursing background (Registered Nurse, Nurse Practitioner, or equivalent) is preferred.
• Bachelor's or Master's degree in Nursing, Health Sciences, or Clinical Research.
• Experience in clinical trials, site management, or research coordination.
• Knowledge of ICH-GCP, Health Canada regulations, and clinical trial operations.

Skills & Competencies

• Strong leadership and problem-solving abilities.
• Excellent communication and interpersonal skills for working with diverse teams.
• Attention to detail and ability to manage multiple sites and priorities.
• Knowledge of electronic data capture (EDC) systems and clinical trial software.

Work Environment:

• May require frequent travel to clinical trial sites.
• Work in hospitals, research centers, or pharmaceutical companies.
• Hybrid or remote work options may be available depending on the employer.

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