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Senior Clinical Research Associate
Alira Health. Conduct site monitoring responsibilities for clinical trials independently .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, ensuring compliance with ICH GCP guidelines, FDA regulations, and SOPs. Proficient in managing study budgets, conducting site visits, and maintaining data integrity while fostering strong relationships with sponsors and study sites.
Highest-signal resume keywords
Clinical Monitoring ExperienceICH GCP ComplianceOncology ExperienceClinical Trial Management SystemsBachelor of Science in Biology
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial MonitoringProtocol ComplianceData Integrity VerificationBudget ManagementSite Contract NegotiationAdverse Event ReportingQuality ControlProblem-Solving StrategiesMonitoring Visit ReportsRegulatory Binder Review
Soft Skills
Strong Organizational SkillsExcellent Communication SkillsLeadership SkillsCustomer Service OrientationAbility to Multitask
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, quality, adherence to SOPs, timelines, and budget requirements
- 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, training presentations, ethics documentation, and site contract negotiation
- Provide monthly billing information to the finance team
- 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 covering site problems, resolutions, protocol deviations, study progress, and enrollment
- Verify source documents and ensure CRF data integrity
- Perform quality control and verification of eTMF/TMF documents
- Conduct investigational product accountability and review site regulatory binders
- Maintain regular contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests
- Ensure compliance with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs
- 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
- Prepare study sites for audits
- Mentor CRAs and assist with CRA onboarding and training
- Collaborate on the development and maintenance of the Clinical Trial Management System (CTMS)
- Manage conflicting priorities and perform additional assigned duties
Requirements
What you’ll need- Minimum 3 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry
- Ability to autonomously manage monitoring activities
- Availability to travel all over Romania
- Oncology experience
- Fluent in Romanian and English; any other language is a plus
- Strong command of the local language, both written and verbal, in the country where monitoring activities are performed
- Graduation in a scientific health field
- Adequate English
- Quality-focused, careful, thorough, and detail-oriented
- Strong organizational skills and ability to multitask in a fast-paced environment
- Ability to manage priorities, organize time, and solve problems
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Ability to travel and manage stress
- Professional, trustworthy, and disciplined
- Ability to solve unstructured or ambiguous challenges
- 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, local regulations, regulatory and ethical requirements
- Ability to establish and maintain positive relationships with sponsors, sites, and project team members
- Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy
Benefits
Comp & perks- Remote work arrangement
- Part-time schedule
- Freelance/contingency workforce engagement