Clinical Research Associate

About Grifols

Join an international team at Grifols, a global pioneer in healthcare since 1909 dedicated to advancing health and wellness worldwide. As leaders in plasma-derived and transfusion medicines, Grifols develops, manufactures, and markets innovative medical solutions in over 110 countries, fostering a diverse and inclusive workplace culture committed to equal employment opportunities.

Position Overview

The Clinical Research Associate plays a vital role in supporting clinical trial management to ensure studies meet timelines and quality metrics. This position involves overseeing vendor activities, ensuring compliance with regulatory and internal standards, and verifying adherence to International Council on Harmonisation Good Clinical Practice (ICH GCP) guidelines along with study protocols.

Primary Responsibilities

• Support clinical monitoring to guarantee sites meet regulatory, ICH GCP, SOPs, and protocol requirements while maintaining study timelines.
• Develop a solid understanding of the therapeutic area and products involved.
• Participate in trial document reviews, including case report form development, IXRS setup, central lab setup, and vendor selection, providing training to others when applicable.
• Conduct and oversee Pre-Study, Site Initiation, Interim Monitoring, and Close-Out Visits to ensure protocol and regulatory compliance.
• Assist in addressing issues escalated from study sites or regulatory bodies, with supervisory support as needed.
• Perform Sponsor Site Visits to demonstrate monitoring oversight and document findings thoroughly.
• Manage study centers to ensure timely and quality clinical study execution, safeguarding subject well-being and study integrity.
• Contribute to study documentation creation, review, and trial master file management with supervisory guidance.
• Support clinical trial materials management, including regulatory document review, investigational product release, and handling technical complaints or recalls.
• Assist with investigator site payments and efficient retrieval and review of study documents related to site activation and start-up.
• Facilitate meetings such as Investigator and Kick-off Meetings, and support monitor training and issue resolution.
• Review and track monitoring reports generated by vendors and verify study documents for completeness and accuracy to uphold data integrity.
• Maintain and update clinical trial management systems with study-specific information.
• Support vendor management activities including performance evaluation and communication management.
• Conduct on-site monitoring visits and activities, including investigator qualification, clinical supply reconciliation, data query resolution, and documentation of site findings and corrective actions.
• Monitor safety processes, including the distribution and tracking of serious adverse events, safety documentation, and pregnancy monitoring, ensuring compliance.

Required Qualifications and Experience

• Minimum of two years in clinical research, including at least one year of field monitoring experience such as independent monitoring, co-monitoring, or accompanied site visits.
• Associate degree in a life sciences field is mandatory; a bachelor's degree or higher is preferred.
• Demonstrated knowledge and experience in clinical research, monitoring, and vendor management.

Benefits

• Competitive salary package.
• Group pension scheme with company matching contributions of 1.5%, 3%, 5%, or 7%.
• Private medical insurance coverage for employees.
• Opportunities for continued career growth within a rapidly expanding organization.
• Succession planning and potential for internal promotions.
• Education allowance.
• Wellness and social activities including padel and summer events.

Additional Information

Grifols is dedicated to fostering diversity and inclusiveness and encourages all candidates who meet the qualifications to apply. The position is located at Grange Castle International Business Park, Dublin, Ireland.