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Clinical Research Associate II
CTI Clinical Trial and Consulting Services. Serve as the main CTI contact for assigned study sites .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, including site management, regulatory compliance, and investigator site file management. Proficient in developing subject enrollment strategies and conducting training for Clinical Research Associates.
Highest-signal resume keywords
Clinical Trial Monitoring ExperienceRegulatory ComplianceSite Management ActivitiesBachelor's Degree in Allied HealthFluent in English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Site InitiationInterim MonitoringClose-Out VisitsCRF RetrievalSource Document VerificationStudy-Specific TrainingPatient Information Sheet TranslationProtocol Synopsis ReviewData-Cleaning ActivitiesSite Contract Negotiations
Soft Skills
CommunicationMentoringTeam CollaborationProblem-SolvingPresentation Skills
Industry Keywords
ICH GCPSOPsClinical ResearchPharmaceutical CompanyCRORegulatory AuthoritiesEthics CommitteesInvestigator PaymentsTrial Master FilesClinical Data Management
About the role
Key responsibilities & impact- Serve as the main CTI contact for assigned study sites
- Conduct pre-study, site initiation, interim monitoring, and close-out visits
- Complete site visit deliverables according to monitoring plans, timelines, regulatory requirements, SOPs, and ICH GCP
- Assist with study start-up, feasibility, pre-study activities, and site selection
- Collect, review, and track essential and regulatory documents
- Complete required general and study-specific training
- Participate in investigator, client, and project team meetings, including presentations
- Create and implement subject enrollment strategies
- Ensure proper storage, dispensation, and accountability of investigational products and trial materials
- Perform site management activities and provide site-status updates to the Clinical Project Manager
- Conduct remote monitoring according to study-specific monitoring plans
- Track subject status, CRF retrieval/source document verification, regulatory documents, and investigational products using systems and reports
- Support project-specific activities as a Project Team member
- Participate in developing CRFs and other study-related documents
- Translate, customize, and review patient information sheets, informed consent forms, protocol synopses, and other applicable documents
- Support Regulatory Affairs Study Start-up with submissions to ethics committees, regulatory authorities, competent authorities, and institutional boards where applicable
- Provide regular updates to sponsors/clients
- Support site contract negotiations, investigator payments, and site-payment tracking where applicable
- Manage investigator site files and trial master files for assigned sites
- Identify and anticipate site issues, implement corrective actions, or escalate as appropriate
- Liaise with Clinical Data Management on data-cleaning activities
- Mentor and train CRAs, including conducting training/assessment visits
- Function as Lead CRA for assigned projects
Requirements
What you’ll need- At least 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
- Fluent in English
- Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health/natural science; or RN with Associate's Degree; or 3-year Nursing Diploma with at least 2 years of clinical nursing experience; or equivalent experience as determined by CTI Management and Human Resources
- Previous experience conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO
- Fully eligible to work in Brazil
- CTI does not provide visa sponsorship
- Proficiency in Spanish is considered an asset
Benefits
Comp & perks- Structured mentoring program
- Leadership development courses
- Dedicated training department
- Ongoing education support
- Hybrid work opportunities
- CTI Cares community and charitable involvement opportunities
- Work contributing to the development of life-changing treatments