Project Coordinator II

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

📋 Description

• Oversee designated site activation tasks within set timelines and quality benchmarks

• Organize, gather, review, and authorize essential regulatory and clinical trial documents from investigator sites

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

• Liaise with Clinical Operations, Regulatory, and Data Management teams

• Recognize activation risks or delays and escalate these issues to the Project Manager

• Ensure the accuracy, completeness, and compliance of essential documents

• Keep current information updated in CTMS, eTMF, and other tracking systems

• Draft meeting minutes, study trackers, and reports for internal and client use

• Assist with submissions to ethics committees and fulfill country-specific regulatory obligations

• Arrange training assignments and maintain documentation specific to project training

• Create and send out study correspondence, site communications, and tracking documentation

• Handle logistics for investigator meetings, study supplies, and ISF distribution

• Engage in audits and inspections and assist in responding to findings

• Aid in process enhancements, documentation of best practices, and initiatives for SOP compliance

• Mentor junior coordinators on standard procedures and administrative tasks

⛳️ Requirements

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

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

• Strong grasp of GCP, ICH guidelines, and clinical documentation standards

• Excellent interpersonal and organizational skills, with the capability to prioritize and manage various tasks

• Outstanding written and verbal communication skills in English; bilingualism is an advantage

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

• Solid understanding of relevant Health Canada and FDA regulations/guidelines

• Indero exclusively accepts applicants eligible to work legally in Canada

🏝️ Benefits

• Flexible working hours

• Permanent full-time role

• Comprehensive company benefits package

• Continuous learning and development opportunities

• Remote work position

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