Senior Clinical Research Associate

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

📋 Description

• Carry out site monitoring duties for clinical trials.

• Offer leadership, oversight, and guidance in the management and execution of clinical trials.

• Ensure adherence to protocols and maintain quality standards.

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

• Facilitate timely and appropriate investigator site visits.

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

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

• Support ethics documentation and the negotiation of site contracts.

• Provide monthly billing details to the finance team.

• Oversee study budgets and serve as the sponsor contact for standalone projects.

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

• Generate precise and timely monitoring visit reports.

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

• Carry out quality control and verification of eTMF/TMF documents.

• Manage investigational product accountability.

• Review site regulatory binders.

• Maintain communication with study sites to guarantee protocol/GCP compliance and monitor patient accrual.

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

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

• Address data discrepancies in collaboration with CRAs/CTC and data management.

• Identify site-related issues and formulate problem-solving strategies.

• Prepare for audits at study sites.

• Assist in the training and onboarding of CRAs and provide mentoring.

• Collaborate on the development and maintenance of the CTMS.

• Manage conflicting priorities and perform additional assigned tasks.

⛳️ Requirements

• At least 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO sector for EU roles.

• Capability to independently manage monitoring activities.

• Strong proficiency in the local language, both written and spoken, in the country where monitoring occurs.

• Adequate command of English.

• Degree in a scientific health-related field.

• Willingness to travel.

• Familiarity with clinical research, ICH GCP, and local regulations.

• Understanding of regulatory and ethical standards.

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

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

• Strong organizational, analytical, negotiation, meeting management, cross-functional teamwork, and leadership abilities.

• Capable of managing priorities, organizing time effectively, and resolving issues.

• For EU (Italy): Certified Monitor in accordance with the Italian CRO decree dated 15 Nov 2011.

🏝️ Benefits

• Opportunities for professional development.

• Global travel prospects.

• Flexible work programs.