Senior Clinical Research Associate

Alira Health

. Conduct site monitoring responsibilities for clinical trials independently .

Posted 9/24/2026full-timeRemote • SpainSenior💰 €45,000 - €60,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical trial monitoring, ensuring compliance with ICH GCP, FDA regulations, and company SOPs. Proficient in managing study budgets, conducting site visits, and providing leadership and guidance to CRA teams.

Highest-signal resume keywords

Clinical Monitoring ExperienceOncology ExpertiseICH GCP ComplianceClinical 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 ComplianceData Integrity VerificationSite Regulatory Binder ReviewAdverse Event ReportingBudget ManagementProblem-Solving StrategiesMonitoring Visit Report PreparationInvestigator Site VisitsStudy-Specific Monitoring Plans

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsLeadership SkillsAbility to Manage StressCustomer Service Orientation

Tools & Technologies

Clinical Trial Management SystemsElectronic Data CaptureClinical Trial Databases

Industry Keywords

Pharmaceutical IndustryBiotechnologyCRO IndustryRegulatory RequirementsEthical Requirements

About the role

Key responsibilities & impact

Conduct site monitoring responsibilities for clinical trials independently
Provide oversight, leadership, and guidance in the management and execution of clinical trials
Ensure protocol compliance and quality
Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
Review monitoring visit reports and conduct co-monitoring and evaluation visits
Ensure appropriate and timely investigator site visits
Coordinate cross-functional departments to resolve clinical trial monitoring issues
Assist with study-specific Monitoring Plans and training presentations
Assist with ethics documents 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 accurate monitoring visit reports documenting site problems, resolutions, actions, protocol deviations, study progress, and enrollment
Ensure CRF data integrity through source document review and verification
Perform quality control and verification of site documents for eTMF/TMF
Conduct investigational product accountability
Review site regulatory binders
Maintain contact with study sites to ensure protocol/GCP compliance and assess patient accrual
Ensure compliance with ICH GCP, FDA regulations, and company/Sponsor SOPs
Participate in internal, client/sponsor, scientific, and other meetings
Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
Resolve discrepant data queries with in-house CRAs/CTC and data management
Identify site issues and develop problem-solving strategies
Conduct audit preparation at study sites
Collaborate with other CRAs
Assist in CRA new-hire training and onboarding
Mentor CRAs
Collaborate on the development and maintenance of the CTMS
Manage conflicting priorities and deliver on commitments
Perform additional assigned duties

Requirements

What you’ll need

Minimum 3 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities
Experience in Oncology
Availability to travel
Quality focused; Proven ability to be careful, thorough, and detail-oriented
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
Able to manage priorities, organize time and solve problems
Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
Ability to travel
Ability to manage stress
Professional, trustworthy and disciplined
Ability to problem-solve unstructured or ambiguous challenges
Strong command of 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, with ability to use clinical trial management systems, clinical trial databases and electronic data capture
Self-starter who thrives in a collaborative, yet less structured team environment
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
EU: Graduation in a scientific health field
EU: Adequate English
Bachelor of Science (BS) in Biology, Biotechnology, Life Sciences, or Pharmacy