Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Responsibilities

Take on the role of monitoring investigator sites strategically, analyzing root causes, and implementing solutions to improve compliance and minimize risks.

• Assess investigational products through physical inventory and records review.
• Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring activities.
• Promptly report observed deficiencies and issues to clinical management and follow through to resolution.
• Maintain continuous contact with investigative sites to confirm protocol adherence, resolve issues, and ensure timely data recording.
• Conduct monitoring tasks and visits according to the approved monitoring plan.
• Collaborate with project team members to resolve issues/findings.
• Provide trial status tracking and progress updates to the Clinical Team Manager (CTM).
• Update study systems per agreed study conventions (e.g., Clinical Trial Management System, CTMS).
• Participate in investigator meetings as necessary.
• Identify potential investigators to ensure the acceptability of qualified sites.
• Commence clinical trial sites in accordance with relevant procedures to guarantee adherence to protocol and regulatory requirements.
• Ensure trial closeout and retrieval of trial materials.
• Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews as per project specifications.
• Contribute to project publications/tools and share ideas/suggestions with team members.
• Facilitate effective communication between investigative sites, the client company, and the PPD project team.
• Complete administrative tasks such as expense reports and timesheets in a timely manner.
• Address company, client, and regulatory needs/audits/inspections.

Requirements

• Oncology highly preferred, bilingual French/English, located in Quebec
• 6 months -1year of direct onsite monitoring experience highly preferred
• Bachelor's degree in a related field or equivalent experience.
• Proven ability to monitor investigator sites and assess investigational product compliance.
• Outstanding critical thinking and problem-solving skills.
• Proficient knowledge of ICH-GCP and regulatory standards.
• Excellent communication and organizational skills.
• Ability to work collaboratively within a team to achieve flawless results.
• Bilingual proficiency in French and English (required for Quebec).

Join us to make a significant impact in the field of oncology research and be part of a world-class team dedicated to scientific excellence!