Senior Clinical Research Associate, Belgium

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

📋 Description

• Execute and oversee clinical monitoring as well as site management functions.

• Conduct both remote and on-site visits to evaluate adherence to protocols and regulatory standards.

• Manage essential documentation, sponsor protocols, and monitoring environments.

• Ensure clinical trials are conducted according to approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Maintain readiness for audits and foster collaborative relationships with investigative sites.

• Monitor investigator sites through risk-based monitoring techniques, including RCA, SDR, SDV, and CRF review.

• Evaluate investigational product inventory and associated records.

• Record observations and elevate deficiencies until resolved.

• Keep in touch with investigative sites in between monitoring visits.

• Track the status of trials and provide progress updates to the Clinical Team Manager.

• Update and perform quality checks on clinical trial management systems.

• Participate in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and manage trial closeout along with the retrieval of materials.

• Ensure that essential documents are complete and conduct on-site file assessments.

• Support project publications, tools, trip report reviews, newsletters, and CRA team discussions.

• Facilitate communication between sites, the client organization, and the project team.

• Address company, client, and regulatory needs, including audits and inspections.

• Complete expense reports and timesheets.

• Contribute to initiatives aimed at process improvement.

• Travel frequently to site locations, generally 60–80%, with potential overnight stays.

⛳️ Requirements

• Bachelor's degree in a life sciences field or a Registered Nursing certification or an equivalent and relevant formal academic/vocational qualification.

• Equivalency may be considered through a combination of suitable education, training, and/or directly related experience.

• A minimum of 2 years of experience as a clinical research monitor.

• Previous experience as an independent monitoring CRA.

• Possession of a valid full driver's license.

• Proficiency in Dutch, English, and French with strong language and grammar skills.

• Effective clinical monitoring abilities.

• Familiarity with medical/therapeutic knowledge and medical terminology.

• Knowledge and application of ICH GCPs, relevant regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving capabilities.

• Ability to manage concepts and processes related to Risk-Based Monitoring.

• Strong oral and written communication skills.

• Excellent interpersonal, organizational, and time-management skills.

• Proficient in Microsoft Office and capable of learning relevant software.

• Competence in presentation skills.

• Capability to work independently or collaboratively within a team.

• Flexibility and adaptability in various situations.

• Ability to meet sponsor/client/site requirements.

🏝️ Benefits

• Fully remote work option in Belgium or hybrid/office-based from the Brussels location.

• Full-time employment opportunity.

• Standard Monday to Friday work schedule.