FSP Clinical Research Associate I/II - Oncology (Quebec or Ontario)

Work Schedule

Environmental Conditions

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 or ON
• Oncology highly preferred located in Ontario
• 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!