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Clinical Trial Coordinator
Alira Health. Assist the clinical research team, supporting Project Managers, Study Start-up team, Clinical Research Associates, and clinical sites to ensure studies comply with ICH GCP, applicable laws, SOPs, and protocols while respecting budgets and timelines .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research support, including compliance with ICH GCP, regulatory submissions, and site management. Proficient in project coordination, communication, and maintaining quality control of essential documents throughout the study lifecycle.
Highest-signal resume keywords
ICH GCP ComplianceRegulatory SubmissionsSite ManagementMS Office Suite ProficiencyStrong Communication 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 Research SupportSite Start-Up ActivitiesFeasibility ActivitiesTrial Master File ManagementDocument TranslationBudget NegotiationProject ReportingCTMS UpdatesEssential Document ReviewStudy-Specific Trackers
Soft Skills
Detail-OrientedOrganizational SkillsAnalytical SkillsProblem-SolvingInterpersonal Skills
Industry Keywords
Ethics CommitteeInstitutional Review BoardRegulatory RequirementsStudy LifecycleCustomer Service Orientation
About the role
Key responsibilities & impact- Assist the clinical research team, supporting Project Managers, Study Start-up team, Clinical Research Associates, and clinical sites to ensure studies comply with ICH GCP, applicable laws, SOPs, and protocols while respecting budgets and timelines
- Conduct site identification and feasibility activities, including outreach, follow-up, and circulation/collection of feasibility questionnaires and NDAs
- Support internal, client/sponsor, scientific, and other meetings through scheduling, agenda preparation, and meeting minutes
- Perform site start-up activities, including Ethics Committee, Institutional Review Board, and regulatory submissions, plus site contract and budget negotiation
- Maintain relationships with Ethics Committees and Competent Authorities
- Set up, maintain, and perform quality control of Trial Master Files
- Support Investigator Site File preparation and distribution
- Support management of study site supplies
- Support collection and review of site Essential Documents with CRAs
- Communicate with sites regarding questions, protocol/GCP compliance, study progress, and subject accrual
- Support study management throughout the study lifecycle, including project reports, CTMS updates, and study-specific trackers
- Maintain study team training materials
- Support site/vendor invoicing management
- Support CRA follow-up activities
- Support document translation
- Participate in audits
- Perform additional assigned duties
Requirements
What you’ll need- Graduation in scientific/health field or equivalent experience
- Strong command of English, both written and verbal
- Proficient with MS Office Suite
- Quality focused; 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 and organize time
- Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges
- Strong communication and interpersonal skills with customer service orientation
- Professional and trustworthy
- Permanent authorization to work in applicable country(-ies)
- Previous experience preferred or ability to quickly learn ICH GCP principles and appropriate Regulatory/Ethical requirements