Site Partner II
Posted 18 hours ago
Posted 18 hours ago
This is a fully remote position, open to applicants in Canada.
• Oversee all essential activities required for the timely activation and maintenance of sites across one or more studies.
• Serve as the site liaison and primary point of contact for escalations, proactively addressing issues to ensure a positive experience for customers.
• Anticipate and plan for Critical Document Package and Site Activation approval timelines within ICON systems.
• Identify delivery risks, develop mitigation and contingency strategies, and escalate issues as necessary.
• Act as the main contact for project managers, clinical trial managers, functional leads, third parties, and key stakeholders.
• Submit protocols, study documentation, and safety reports for approval from local ethics/IRB.
• Prepare documentation for regulatory submissions at the site level.
• Modify and personalize Patient Informed Consents as needed.
• Negotiate Clinical Trial Agreements, budgets, and related agreements as assigned.
• Organize, verify, and maintain site and country documentation within the Trial Master File.
• Coordinate, verify, and back-translate necessary translations for study start-up and maintenance.
• Update site status and input data into tracking and management systems.
• Assist in site selection and qualification processes.
• Relay instructions from sponsors, project managers, country representatives, and clinical trial managers to sites.
• Participate in study team meetings and contribute to initiatives aimed at process improvement, efficiency, and technology adoption.
• Mentor and train personnel within the CDP Review Team.
• Conduct activities in accordance with corporate and departmental policies, SOPs, operating procedures, and guidelines.
• Bachelor's Degree.
• 0-3 years of experience in a Clinical Research setting.
• Strong communication skills.
• Good judgment and decision-making abilities.
• Proficient in computer applications.
• Fluency in the English language is essential.
• Basic knowledge of French is preferred.
• Must have the legal right to work in the country where the position is based.
• Competitive base salary along with performance-related incentives.
• Health and wellness programs, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life insurance and disability coverage.
• Employee assistance programs and wellness resources.
• Opportunities for learning and development through structured training and career pathways.
Kyndryl
ICON plc
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