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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Control activities, ensuring compliance with federal regulations and Advarra standards while effectively communicating feedback and supporting process improvements. Proficient in managing documentation related to Human Subjects Research Protection and executing quality control on various submissions.
Highest-signal resume keywords
Quality Control ExperienceIRB KnowledgeFederal Regulations ComplianceMS Word ProficiencyAttention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality ControlClinical ResearchIRB DocumentationFederal Laws KnowledgeProtocol ModificationsInformed Consent ProceduresData AnalysisDocument ReviewProcess ImprovementSubmission Accuracy
Soft Skills
Verbal CommunicationListening SkillsAdaptabilityTeam CollaborationFeedback Delivery
Tools & Technologies
MS WordOutlookExcelPowerPointSlackZoomWeb-Based Software
Industry Keywords
Human Subjects Research ProtectionAdvarra StandardsQuality Control StandardsClinical Research RegulationsInformed ConsentConflict of InterestSite Reviews
About the role
Key responsibilities & impact- Conduct Quality Control activities on IRB and staff documentation
- Ensure accuracy against primary sources and compliance with Advarra quality control standards, federal regulations, and timelines
- Review and critically analyze assigned submission documents for content accuracy
- Communicate clear feedback to Research Services staff regarding missing or incomplete elements
- Accomplish daily workload priorities with flexibility and adaptability
- Execute procedures in compliance with internal quality standards and external regulations
- Support supervisor or director vision through timely processing of delegated tasks, escalation of workflow concerns, and process improvement suggestions
- Participate in team and department professional and personal development initiatives
- Perform quality control of recruitment, subject-facing, translated, and generic material submissions
- Perform initial site reviews and site modifications, including investigator, location, conflict-of-interest, informed-consent, HIPAA, and eConsent requests
- Perform quality control on study-level Protocol or Product Information modifications that do not impact Informed Consent templates
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor’s degree in health science or related field, or equivalent combination of education and experience
- 1+ year of IRB, clinical research, or quality control experience
- Basic knowledge of federal laws and guidelines pertaining to Human Subjects Research Protection
- Proficient with MS Word and Outlook
- Familiarity with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom, and web-based proprietary software
- Ability to sit or stand for extended periods at a stationary workstation
- Ability to regularly carry, raise, and lower objects up to 10 lbs
- Ability to learn and comprehend basic instructions
- Focus and attention to tasks and responsibilities
- Verbal communication, listening and understanding, responding, and speaking
Benefits
Comp & perks- Variable bonus eligibility
- Health coverage
- Paid holidays
- Other benefits
- Remote work arrangement
