Project Coordinator II

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee designated site activation tasks while adhering to set timelines and quality benchmarks.

• Organize, gather, evaluate, and authorize critical regulatory and clinical trial documents from investigator sites.

• Serve as the main point of contact for assigned sites regarding operational and administrative issues.

• Collaborate with Clinical Operations, Regulatory, and Data Management teams.

• Recognize and elevate potential site activation risks or delays to the Project Manager.

• Keep precise records in the CTMS, eTMF, and other tracking systems.

• Draft meeting minutes, study trackers, reports, study correspondence, and communications with sites.

• Assist in submissions to ethics committees and adhere to country-specific regulatory obligations.

• Manage project-specific training assignments and relevant documentation.

• Coordinate logistics for investigator meetings, distribution of study supplies, and ISF.

• Engage in audits and inspections, providing support for responses to findings.

• Contribute to enhancements in processes, documentation of best practices, and initiatives for SOP compliance.

• Offer guidance and support to junior coordinators.

⛳️ Requirements

• Bachelor’s degree in a field pertinent to clinical research or equivalent experience.

• 1 to 2 years of experience in clinical research, ideally within a CRO, biotech, or pharmaceutical environment.

• Strong knowledge of GCP, ICH guidelines, and standards for clinical documentation.

• Excellent interpersonal and organizational abilities, capable of prioritizing and managing several tasks simultaneously.

• Outstanding written and verbal communication skills in English; bilingual proficiency is a plus.

• Proven ability to work both independently and collaboratively in cross-functional teams.

• Solid understanding of applicable Health Canada and FDA regulations/guidelines.

🏝️ Benefits

• Flexible work schedule

• Permanent full-time position

• Company benefits package

• Ongoing learning and development

• Home-based position

• Comprehensive benefits (medical care, dental care, vision care, RRSP, vacation, personal days, virtual medical clinic, public transport discounts, social activities)