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Senior Clinical Research Associate – Remote
Lifelancer. Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with approved protocols .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical monitoring, including conducting site visits, managing investigational product accountability, and ensuring compliance with protocols and regulatory requirements. Proficient in patient management, documentation practices, and effective communication in both Portuguese and English.
Highest-signal resume keywords
Clinical MonitoringProtocol CompliancePatient ManagementRegulatory DocumentationCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical MonitoringProtocol DevelopmentCase Report Form (CRF) ManagementInvestigator Site File (ISF) DocumentationTrial Master File (TMF) ReconciliationAdverse Event ReportingGood Clinical Practice (GCP)Research Source Documentation VerificationPatient Recruitment StrategiesInventory Management
Soft Skills
Verbal CommunicationWritten Communication
Industry Keywords
Clinical ResearchSite MonitoringRegulatory ComplianceClinical TrialsHealth Sciences
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with approved protocols
- Communicate with medical site staff, including coordinators, clinical research physicians, and site staff
- Verify investigator qualifications, training, resources, facilities, laboratories, equipment, and staff
- Verify medical records and research source documentation against case report form data
- Inform site staff of entry errors and ensure good documentation practices
- Communicate protocol deviations according to SOPs, GCP, and applicable regulatory requirements
- Verify that investigators enroll only eligible subjects
- Review regulatory documents
- Manage investigational product/drug accountability and inventory
- Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses for accurate protocol-compliant reporting
- Assess site patient recruitment and retention and offer improvement suggestions
- Complete monitoring reports and follow-up letters summarizing findings, deviations, deficiencies, and recommended compliance actions
- Participate in clinical research departmental core rotations and drug/device development training
Requirements
What you’ll need- Bachelor's degree in a health or science-related field is required
- 5+ years of experience in clinical monitoring or CRC experience preferred
- Willingness to travel nationwide within Brazil
- Proven experience in clinical patient management
- Experience with protocols and CRFs
- Experience preparing ISF documentation
- Experience reconciling TMF documentation
- Excellent verbal and written communication skills in Portuguese and English
- Application must be submitted in English
Benefits
Comp & perks- Comprehensive initial and ongoing training through the PACE Training Program
- Defined CRA promotion and growth ladder with potential for mentoring and management advancements
- Competitive pay
- Opportunity for significant travel bonus
- Purpose-driven work advancing clinical research and medical therapeutics
- Collaborative culture with open communication and mutual trust
- Office-based environment with on-site mentors
- Defined career paths with clear advancement opportunities
- Industry-renowned onboarding and training programs
- Ongoing training and continuous learning opportunities
- Comprehensive health, wellness, retirement, and PTO benefits
- Office-based culture with occasional work from home for eligible positions after training
- Company-sponsored social events