3 дня назад
Human Research Protection Specialist, DONHRPP, Falls Church, Virginia
58 440 - 93 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Human Research Protection Specialist, DONHRPP, Falls Church, Virginia (Human Research Protection and Regulatory Compliance): Overseeing human research protection programs, IRB protocols, institutional assessments, and regulatory compliance with an accent on federal regulations, Common Rule subparts, HIPAA, and GCP standards. Focus on conducting site inspections, analyzing research documentation, preparing assessment reports, advising HRPP stakeholders, and identifying improvements to policies, systems, and training.
Location: Falls Church, Virginia, United States — onsite at 5205 Leesburg Pike
Salary: $58,440–$93,500 per year, plus potential short-term incentives and benefits.
Company
provides healthcare-related services and employs specialists in human research protection, compliance, and clinical research oversight.
What you will do
- Support the development and implementation of human subject protection standards, policies, procedures, and systems.
- Provide guidance and oversight to assigned Commands and advise Institutional Officials, HRPOs, IRB members, and HRPP staff.
- Review Command Assurances, management plans, instructions, IRB rosters, policies, procedures, agreements, and training records.
- Conduct site inspections and assist visits, including interviews and reviews of research and investigator files.
- Review IRB-approved protocols, track compliance trends, and prepare written assessment reports with findings, recommendations, and impact analyses.
- Identify needs for new processes, systems, guidance documents, standards, and training.
Requirements
- Minimum of 4 years of experience in human research protection and compliance oversight.
- Bachelor’s degree in a biomedical or socio-behavioral field required; a master’s degree is preferred.
- Expertise in human research protection, including the Common Rule and subparts B, C, and D, HIPAA, and other applicable regulatory requirements.
- Exceptional verbal and written communication skills, strong technical writing abilities, and a writing sample.
- Superior analytical, problem-solving, negotiating, project-management, time-management, and change-management skills.
- Interim Secret Clearance required to start; travel to domestic and international destinations may be required up to eight times per year.
Culture & Benefits
- Comprehensive health, life, voluntary, and other benefits.
- Potential eligibility for short-term incentive compensation.
- Tobacco-free workplace.
- Human subjects protection and regulatory compliance certification required or to be obtained within six months of hire.
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