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Clinical Research Associate, CRA
ParexelClinical Research Associate overseeing clinical research studies with primary site management responsibilities. Ensuring compliance with good clinical practices and site relationship management for patient recruitment and retention.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical site management and monitoring, ensuring compliance with ICH/GCP guidelines and effective communication with site staff. Proficient in managing site performance, patient recruitment, and utilizing various clinical IT applications.
Highest-signal resume keywords
Site ManagementClinical Research KnowledgeGCP/ICH ComplianceData AnalysisFluent in English and Local Languages
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 MonitoringClinical Trial PhasesProtocol UnderstandingPatient Recruitment ManagementRegulatory DocumentationSite AuditsVisit ReportingData AnalysisClinical IT ApplicationsMS Office Proficiency
Soft Skills
Strong CommunicationRelationship BuildingProblem Solving
Tools & Technologies
Clinical IT ApplicationsMS OfficeTablet DevicesMobile Devices
Certifications & Qualifications
Current Driver's License
Industry Keywords
Bio/PharmaCROICH GuidelinesGCP GuidelinesLocal Laws and Regulations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
- Gains an in-depth understanding of the study protocol and related procedures
- Performs clinical study site management/monitoring activities in compliance with ICH/GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
Requirements
What you’ll need- Minimum 2 years of direct site monitoring experience in bio/pharma/CRO
- Fluent in local languages and English (verbal and written)
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
- Proven skills in Site Management including management of site performance and patient recruitment
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
- Ability to understand and analyze data/metrics and act appropriately
- Current driver’s license required
Benefits
Comp & perks- Potential for flexible work arrangements
- Professional development opportunities