Senior Clinical Research Associate

Alira Health

. Conduct site monitoring responsibilities for clinical trials .

Posted 10/14/2026full-timeZevenbergen • NetherlandsSenior💰 €60,000 - €80,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, ensuring compliance with ICH GCP and local regulations while effectively managing study budgets and site relationships. Proficient in utilizing clinical trial management systems and electronic data capture tools to maintain data integrity and facilitate communication across cross-functional teams.

Highest-signal resume keywords

Clinical Monitoring ExperienceICH GCP ComplianceOncology ExperienceClinical Trial Management SystemsBachelor of Science in Biology

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MonitoringProtocol ComplianceQuality ControlData Integrity VerificationSite Contract NegotiationAdverse Event ReportingBudget ManagementProblem-Solving StrategiesMonitoring Visit ReportsTraining and Mentoring

Soft Skills

Excellent CommunicationInterpersonal SkillsCustomer Service OrientationAbility to Manage Conflicting PrioritiesRelationship Building

Tools & Technologies

Clinical Trial Management SystemsElectronic Data CaptureETMF/TMF DocumentsClinical Trial Databases

Industry Keywords

Pharmaceutical IndustryBiotechnologyCRO IndustryRegulatory RequirementsEthical RequirementsScientific Health Field

About the role

Key responsibilities & impact

Conduct site monitoring responsibilities for clinical trials
Provide oversight, leadership, and guidance in the management and execution of clinical trials
Ensure protocol compliance, quality, ICH GCP compliance, and adherence to SOPs
Provide guidance, oversight, and feedback to the CRA team
Review monitoring visit reports and conduct co-monitoring and evaluation visits
Ensure timely investigator site visits
Coordinate cross-functional departments to resolve clinical trial monitoring issues
Assist with Monitoring Plans and training presentations
Assist with ethics documentation and site contract negotiation
Provide monthly billing information to finance
Manage study budgets and act as sponsor referent for stand-alone projects
Perform qualification, initiation, interim, and close-out visits remotely and onsite
Prepare monitoring visit reports documenting site issues, resolutions, protocol deviations, study progress, and enrollment
Review source documents and verify CRF data integrity
Perform quality control and verification of eTMF/TMF documents
Conduct investigational product accountability and review site regulatory binders
Maintain site contact, assess patient accrual, and respond to sponsor requests
Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
Resolve discrepant data with in-house CRAs/CTC and data management
Identify site issues and develop problem-solving strategies
Conduct audit preparation at study sites
Mentor CRAs and assist with CRA training and onboarding
Collaborate on the development and maintenance of the CTMS
Manage conflicting priorities and perform additional duties as assigned

Requirements

What you’ll need

Minimum 4 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry
Ability to autonomously manage monitoring activities
Availability to travel in Belgium and the Netherlands
Oncology experience required
Strong command of the local language, both written and verbal, in the country where monitoring activities are performed
Excellent communication and interpersonal skills with customer service orientation
Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture
Knowledge of clinical research, ICH GCP, and local regulations
Knowledge of regulatory and ethical requirements
Ability to establish and maintain positive relationships with Sponsor, Site, and Project Team members
Graduation in a scientific health field
Adequate English
Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy

Benefits

Comp & perks

Remote work
Regular employment contract
Global team collaboration across time zones
Professional development through CRA new hire training, onboarding, and mentoring