Senior Clinical Research Associate – FSP

This is a fully remote position, open to applicants in Finland.

📋 Description

• Ensure the proper execution of clinical trials in alignment with the Study Monitoring Plan and relevant laws, as well as Good Clinical Practices.

• Oversee the operational elements pertaining to the implementation of clinical trial activities at designated investigator sites, from site activation to database lock, ensuring that timelines and quality deliverables are adhered to.

• Collaborate with the study team as necessary, facilitating the flow of information among study team members, vendors, and assigned investigator sites.

• Monitor site-level Adverse Events (AEs) and Serious Adverse Events (SAEs), working with the Drug Safety Unit, and following up with investigator sites as required to resolve SAE reports with the necessary information.

• Act as a primary contact for audit processes, and oversee the development and verification of Corrective and Preventive Actions (CAPA) for Audit Observations, when applicable.

⛳️ Requirements

• Bachelor’s degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or a medical background, or an equivalent qualification.

• Comprehensive understanding of clinical trial methodologies, ICH/GCP guidelines, FDA regulations, and local country laws.

• At least 3.5 years of relevant experience in clinical research site monitoring, preferably within the Oncology field.

• Preferred therapeutic experience includes Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

🏝️ Benefits

• N/A