Research Specialist, Human Subjects Research
Ripple Effect
Research Analyst – Human Subjects Research
Ripple Effect
full-time
Posted on:
Origin: • 🇺🇸 United States • District of Columbia, Washington
Visit company websiteSalary
💰 $82,858 - $84,500 per year
Job Level
Mid-LevelSenior
About the role
- Conduct comprehensive reviews and evaluations of human subjects research protocol submissions, including amendments, continuing reviews, continuations, and final study reports
- Provide real-time assistance to the development and review of DHS-supported research protocols to ensure 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, identifying deficiencies and areas of noncompliance
- Support DHS HRPG Lead Analyst and federal staff in analyzing complex regulatory and ethical issues and prepare administrative support for reporting recommendations to executive management
- Actively 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 (HRPG) team
Requirements
- MA/MS in a life science, biomedical, or related field
- 4 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 to address deficiencies or noncompliance in human research conduct
- 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 among multiple projects in a fast-paced, deadline-driven environment
- Strong skills in MS Office, SharePoint, and OneDrive
- Must work effectively in a team environment
- United States citizenship required by government contract
- Public Trust clearance required (or ability to obtain)
- Desirable: CIP, SOCRA, or similar certifications; CITI training; IRB service or administration experience; government contractor experience supporting DHS; ability to travel locally/regionally/nationally
