Senior Clinical Research Associate

This is a fully remote position, open to applicants in Netherlands, +1 more country.

📋 Description

• Perform site monitoring duties for clinical trials conducted in the Netherlands and Belgium.

• Provide leadership, oversight, and direction in the management and execution of clinical trials.

• Collaborate with clinical monitoring directors, lead CRAs, in-house CRAs, CRAs, and project managers.

• Ensure compliance with protocols, quality standards, SOP adherence, timelines, and budget constraints.

• Review monitoring visit reports and conduct co-monitoring and evaluation visits as necessary.

• Ensure timely visits to investigator sites.

• Coordinate with cross-functional departments to address clinical trial monitoring challenges.

• Assist in the development of study-specific monitoring plans and training presentations.

• Support the collection of ethics documentation and negotiations for site contracts.

• Provide monthly billing details to the finance team.

• Manage study budgets and serve as the sponsor representative for stand-alone projects.

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

• Prepare accurate and timely reports for monitoring visits.

• Verify source documents and ensure the integrity of CRF data.

• Carry out quality control and document verification for eTMF/TMF.

• Conduct accountability assessments of investigational products and review regulatory binders.

• Maintain communication with study sites, evaluate patient accrual, and respond to sponsor inquiries.

• Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs.

• Facilitate adverse-event reporting and reconcile SAE reports with source documents and CRFs.

• Resolve data discrepancies in collaboration with in-house CRAs/CTC and data management teams.

• Identify site issues and formulate problem-solving strategies.

• Prepare study sites for audits.

• Mentor CRAs and assist in their training and onboarding processes.

• Collaborate on the creation and upkeep of the CTMS.

• Manage competing priorities and undertake additional assigned tasks.

⛳️ Requirements

• A BS/BA degree in life sciences or a related field is preferred (US).

• At least 2 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO sector (EU).

• Ability to independently manage monitoring activities (EU).

• Strong proficiency in the local language, both written and verbal, in the region where monitoring is conducted (Dutch and English).

• Adequate proficiency in English (EU).

• Willingness to travel.

• Knowledge of clinical research practices, ICH GCP, and local regulations.

• Familiarity with regulatory and ethical standards.

• Strong computer skills, including proficiency with clinical trial management systems, clinical trial databases, and electronic data capture.

• Ability to establish and maintain positive relationships with sponsors, study sites, and project team members.

• A degree in a scientific health field (EU).

• Excellent organizational, analytical, negotiation, meeting management, cross-functional collaboration, leadership, and problem-solving skills.

🏝️ Benefits

• Opportunities for professional development.

• Global travel experiences.

• Flexible work arrangements.