Senior Clinical Research Associate – FSP

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

📋 Description

• Carry out site management tasks to guarantee adherence to the protocol, monitoring plan, ICH GCP, local regulatory standards, and sponsor SOPs.

• Execute site qualification, initiation, interim, and close-out visits, both on-site and remotely.

• Collaborate with the Clinical Trial Liaison (CTL) and other sponsor departments to facilitate site activation and deliverables.

• Build and sustain effective professional relationships with investigator site personnel.

• Conduct drug accountability, reconciliation, and destruction, ensuring compliance with the protocol.

• Prepare and uphold the Oversight Monitoring Plan.

• Carry out Oversight Monitoring Visits at various sites.

• Assess and report on the status of study execution at the investigator site.

• Ensure that site regulatory files are updated and that study documentation is submitted promptly.

• Identify and document protocol deviations, escalate non-compliance issues, and resolve study-related challenges.

• Maintain continuous communication with site staff, study teams, and other relevant stakeholders.

• Assist with inspection readiness activities and uphold data integrity and protocol commitments.

⛳️ Requirements

• Bachelor's degree or equivalent qualification.

• At least 5 years of relevant experience for Senior Clinical Research Associate (CRA).

• Strong analytical and problem-solving skills alongside critical thinking capabilities.

• Working knowledge of the clinical drug development process, ICH GCP guidelines, and relevant regulatory requirements (e.g., FDA, EMA, PMDA).

• Excellent communication and interpersonal skills to foster relationships both internally and externally.

• Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories.

• Proven ability to produce clear and concise written reports.

• Effective prioritization and time management skills.

🏝️ Benefits

• Health insurance.

• Paid time off.

• Opportunities for professional development.