FSP Clinical Research Associate I Oncology (Quebec or Ontario)
FSP Clinical Research Associate I Oncology (Quebec or Ontario)
Posted on :
21-09-2025
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1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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
- Bachelors 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!
Required Experience:
IC
Employment Type
Full-Time
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