
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.
🔥 2 minutes ago
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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.
• Provide administrative and coordinating support for site activation activities and other site-level deliverables throughout all phases of the clinical trial lifecycle • Lead efforts to ensure timeframes, targets, and deliverable quality meet internal and external customer expectations • Work with Project Managers, Clinical Trial Managers, Site Selection Team, and Clinical Research Associates • Prepare investigator sites to conduct clinical trials through review and approval of essential clinical trial and regulatory documents • Establish site activation timelines and coordinate activities to meet planned activation 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 • Communicate with study teams and external site staff to align tasks and priorities with study timelines • Collect, review, file, and distribute essential site documents • Ensure eTMF contains relevant regulatory documents for site activation and ongoing study management • Produce meeting minutes and maintain the ADI log • Assign documents for internal project-specific training and coordinate training reconciliation and documentation • Assist with drafting study documents and study plans • Serve as main contact for site correspondence on non-protocol-related issues • Assist sites with local ethics submissions and teams with access to study-specific systems • Initiate and maintain study files • Assemble and ship Investigator’s Study Files • Maintain project timelines, enrollment tracking tools, and study material inventory • Prepare shipments of study supplies to clinical sites when applicable • Assist with Investigators’ Meetings • Serve as in-house contact supporting 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, audit preparation, and CAPA preparation as needed • Perform project management duties on designated trials as needed • Mentor junior Project Coordinators and assist with onboarding • Assist with process improvement and creation of training material
• 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 • 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 Power Point • 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 Food and Drug Administration (FDA) regulations/guidelines
• Flexible work schedule • Permanent full-time position • Company benefits package • Ongoing learning and development • Attractive advancement opportunities • Stimulating work environment
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