Thermo Fisher Scientific
Clinical Research Associate (Level II) - Montreal, QC Canada
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Healthtech • Biotech • Pharmaceutical • Manufacturing
As a Clinical Research Associate, you will monitor clinical trial sites, ensure compliance with protocols, and support site staff while managing multiple projects.
Top Skills:
Clinical Trial Software And ToolsGood Clinical Practice (Gcp)
Healthtech • Biotech • Pharmaceutical • Manufacturing
As a Senior Clinical Research Associate, you will monitor clinical studies, ensuring compliance with protocols and regulatory requirements. You will work both on-site at investigative sites and remotely, focusing on data integrity and patient safety.
Biotech
The Senior Clinical Research Associate manages clinical study sites for data quality and patient safety, mentors CRAs, and ensures regulatory compliance.
Top Skills:
CtmsData Management SystemsExcelMicrosoft WordOutlookPowerPoint
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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!
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