Regulatory Coordinator ensuring compliance with research operations and documentation for clinical studies. Collaborating with research teams to maintain regulatory standards and support project objectives.
About the role
- Senior Clinical Research Associate overseeing clinical trial activities at ICON plc. Ensuring data integrity and compliance throughout the study lifecycle with various responsibilities.
Responsibilities
- Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
- Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
- Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
- Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
Requirements
- Advanced degree in a relevant field such as life sciences, nursing, or medicine.
- Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
- Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
- Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
- Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Job title
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