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About the role
- Senior Project Coordinator supporting clinical trial site activation at Indero, a dermatology-focused CRO. Coordinating regulatory documents, timelines, site communications, and study deliverables across clinical trials.
Responsibilities
- Provide administrative and coordinating support for site activation activities and site-level deliverables throughout the clinical trial lifecycle
- Prepare investigator sites to conduct clinical trials by reviewing and approving essential clinical trial and regulatory documents
- Establish site activation timelines and coordinate activities to meet planned timelines
- Communicate with clinical sites during site start-up
- Collaborate with functional departments to align activities with site activation targets
- Escalate site activation schedule risks to the Project Manager
- Coordinate with study teams and external site staff to align tasks and priorities with study timelines
- Collect, review, file, and distribute essential site documents
- Ensure documentation quality and completeness for first-pass site activation review
- Maintain the electronic Trial Master File (eTMF) with relevant regulatory documents
- Produce meeting minutes and maintain the ADI log
- Assign project-specific training documents and coordinate training reconciliation and documentation
- Assist with drafting study documents and study plans
- Serve as the main contact for non-protocol site correspondence
- Assist sites with local ethics submissions
- Support access to study-specific systems and maintain study files
- Assemble and ship Investigator Study Files and study supplies
- Maintain project timelines, enrollment tracking tools, and study material inventory
- Assist with Investigators’ Meetings
- Support CRAs when traveling
- Review and reconcile investigator site and vendor payments
- Assist with project tracking and status report preparation
- Support Health Authority inspections, pre-inspection activities, audits, and CAPA preparation
- Perform project management duties on designated trials
- Mentor junior Project Coordinators and assist with onboarding
- Support process improvement and creation of training materials
Requirements
- Minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry
- Proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment
- Bachelor’s degree in a field relevant to clinical research or equivalent experience
- Good knowledge of essential documentation requirements for clinical trials
- Proficiency in English (written and oral) is required
- Bilingual French and English or fluency in another European or Asian language is an asset
- Excellent knowledge and competency in Word, Excel, and PowerPoint
- Ability to prioritize multiple assignments to meet deadlines
- Attention to detail
- Quick learner, good adaptability and versatile
- Strong organizational, communication, problem-solving and multi-tasking skills
- Good knowledge of good clinical practices and applicable Health Canada and FDA regulations/guidelines
- Applicants must be legally authorized to work in Canada
Benefits
- Permanent full-time position
- Flexible schedule
- Home-based position
- Ongoing learning and development
- Comprehensive benefits package: medical, dental and vision insurance, retirement plan, vacation, personal days, virtual medical clinic, public transit discount, and social activities
- Occasional visits to the head office may be required or encouraged
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