Senior Project Coordinator

Job not on LinkedIn

🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

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Logo of Innovaderm Research Inc.

Innovaderm Research Inc.

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• 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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