Senior Clinical Research Associate - FSP

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

📋 Description

• Ensure the appropriate conduct of clinical trials in alignment with the Study Monitoring Plan and the relevant laws and Good Clinical Practices.

• Oversee the operational facets for executing clinical trial activities at designated investigator sites, from site activation to database lock, ensuring that timelines and quality deliverables are achieved.

• 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), collaborating with the Drug Safety Unit and following up with investigator sites as needed to resolve SAE report requirements.

• Act as a point of contact during audits, and lead the development and verification of Corrective and Preventive Actions (CAPA) for Audit Observations, when necessary.

⛳️ Requirements

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

• In-depth knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations.

• A minimum of 3.5 years of relevant experience in clinical research site monitoring, preferably in Oncology.

🏝️ Benefits

• Flexible working arrangements.