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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 extensive experience in clinical trial monitoring, ensuring protocol compliance and quality while managing study budgets and investigator site visits. Proficient in collaborating with cross-functional teams and mentoring clinical research associates to enhance trial execution and compliance.
Highest-signal resume keywords
Clinical Monitoring ExperienceOncology ExpertiseICH GCP ComplianceClinical Trial Management SystemsBachelor of Science in Life Sciences
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site MonitoringProtocol ComplianceQuality ControlData VerificationAdverse Event ReportingProblem-Solving StrategiesBudget ManagementInvestigator Site VisitsStudy RecruitmentRegulatory Binder Review
Soft Skills
Strong Organizational SkillsAnalytical SkillsLeadership SkillsInterpersonal SkillsCustomer Service Orientation
Tools & Technologies
Clinical Trial Management SystemsElectronic Data CaptureClinical Trial Databases
Industry Keywords
Pharmaceutical IndustryBiotechnologyCRORegulatory RequirementsEthical RequirementsGCP GuidelinesFDA Regulations
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
- Collaborate with clinical monitoring, CRA, in-house CRA, data management, project management, and sponsor teams
- Assist with study recruitment, site training, and site-related issues
- Provide guidance, oversight, and feedback to the CRA team
- 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 and timely monitoring visit reports
- Review and verify source documents and CRF data
- Perform quality control and verification of eTMF/TMF documents
- Conduct investigational product accountability
- Review site regulatory binders
- Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests
- 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
- Assist with CRA new hire training and onboarding
- Mentor CRAs
- Collaborate on 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
- Ability to autonomously manage monitoring activities
- Experience in Oncology
- Availability to travel in Netherland and Belgium
- 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
- EU: 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
- Ability to perform site visits remotely and onsite
- Ability to comply with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs
Benefits
Comp & perks- Remote work arrangement
- Part-time work schedule