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Research Analyst, Human Subjects
Ripple Effect. Conduct comprehensive reviews and evaluations of human subjects research protocol submissions, including amendments/addenda, continuing review reports, protocol continuations under new awards, and final study reports .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in human subjects research compliance, regulatory review, and quality assurance, with a strong focus on attention to detail and effective communication. Proficient in managing protocol submissions and collaborating with multidisciplinary teams to ensure adherence to federal and state regulations.
Highest-signal resume keywords
Human Subjects Research ComplianceRegulatory Review RecommendationsQuality Control and AssuranceCIP CertificationIRB Administration Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory ComplianceProtocol ReviewQuality AssuranceData ManagementResearch Protocol DevelopmentDeficiency IdentificationReport WritingBiomedical Research KnowledgeAttention to DetailProject Prioritization
Soft Skills
Excellent Communication SkillsCollaborationTime ManagementProblem-SolvingCommitment to Quality
Tools & Technologies
Microsoft OfficeMicrosoft TeamsSharePointGenerative AIAutomation Tools
Certifications & Qualifications
CIPSOCRACITI Training
Industry Keywords
Human Subjects Protection RegulationsDHSFederal RegulationsBiomedical ResearchIRB
About the role
Key responsibilities & impact- Conduct comprehensive reviews and evaluations of human subjects research protocol submissions, including amendments/addenda, continuing review reports, protocol continuations under new awards, and final study reports
- Provide real-time assistance in developing and reviewing DHS-supported research protocols for regulatory compliance
- Ensure ongoing compliance with Federal, DHS, state, local, and other human subjects protection regulations and guidelines
- Provide regulatory-based written reviews using standardized checklists
- Identify deficiencies and areas of noncompliance in protocol submissions
- Support the DHS HRPG Lead Analyst and relevant federal staff in analyzing complex regulatory and ethical issues
- Provide administrative support for reporting recommendations to executive management
- Manage and update protocol files and information management systems related to protocol review
- Work with senior scientists as part of a Human Research Protection Group team
Requirements
What you’ll need- Bachelor's Degree in a life science, biomedical, or related field
- 6 years of relevant professional experience
- Experience applying laws, regulations, policies, procedures, and guidelines governing human subjects research and cadaver use
- Experience making regulatory review recommendations addressing deficiencies or noncompliance in human research conduct
- Prior professional experience relating to quality control and/or quality assurance
- Excellent written and oral communication skills
- Ability to work well with various individuals and collaborate across teams
- Ability to prioritize multiple projects in a fast-paced, deadline-driven environment
- Exceptional attention to detail and ability to execute instructions
- Commitment to quality and compliance
- Intermediate experience with Microsoft Office productivity software
- Intermediate experience with Microsoft Teams and SharePoint
- Ability to travel locally, regionally, and/or nationally
- Master's Degree in a life science, biomedical, or related field (preferred)
- Relevant certifications, e.g., CIP, SOCRA, etc. (preferred)
- CITI training in accordance with local IRB policy (preferred)
- Experience serving on or administering an IRB (preferred)
- Experience as a government contractor supporting biomedical or health research programs within DHS or other federal systems (preferred)
- Intermediate experience applying generative AI, automation tools, and structured data techniques to support labor estimating, pricing analytics, proposal benchmarking, and decision-making while maintaining appropriate human oversight and quality controls (preferred)
Benefits
Comp & perks- Competitive pay
- Exceptional benefits
- Programs supporting work/life balance
- Personalized preference programs
- Flexible work options