Senior Human Subjects Protection Scientist

About the role

The Senior Human Subjects Protection Scientist supports the Office of Research and Regulatory Compliance (ORRC), Office of Human Research Oversight (OHRO) at Defense Health Agency Research & Development (DHA R&D).

Responsibilities

• Provide regulatory-based written review of protocols using standardized checklists to ensure compliance with all applicable Federal, DoD, FDA, state, host nation, and DHA R&D human subjects protection requirements.
• Review research protocols that have undergone review and approval by the local Institutional Review Board (IRB); delineate deficiencies and areas of regulatory noncompliance and make recommendations to the OHRO Federal Approval Authority (AAs) regarding regulatory and ethical issues in OHRO submissions.
• Work with the investigator to make updates/revisions to the materials to bring the protocol into compliance for OHRO approval.
• Assign a portfolio of protocols for initial review, including determinations of not research, research not involving human subjects, exempt research, non-exempt research, and protocols utilizing cadavers/cadaveric specimens.
• Provide accurate information, assistance, and documents to customers and OHRO Federal personnel when requested with appropriate professionalism in a timely manner.
• Manage the assigned protocol portfolio, including data entry activities and use of OHRO specific information management systems to track information and activities related to protocol review.
• Aid in developing policies, procedures, guidelines, and other materials to ensure compliance with current regulations and update investigators, research managers, and administrators on human subjects protection and regulatory compliance policies and procedures.
• Support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines.
• Facilitate regulatory compliance through education and training of investigators, research managers, administrators, and OHRO staff, and assist with interpreting human subjects protection and cadaver use requirements.
• Stay updated on current Federal, DoD, FDA, Army, state, host nation, and DHA regulatory requirements related to the protection of human subjects in research and cadaver use, and apply knowledge of these regulations and general ethical principles during OHRO reviews.
• Communicate and provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects protection regulations and OHRO requirements.
• Participate in performance improvement activities and task contract personnel to participate in specific working groups to improve and streamline the protocol review and approvals processes, and provide input and assistance with formulating and writing OHRO standard operating procedures and work instructions.

Qualifications

• Education: Bachelor’s Degree in a scientific, or related discipline.
• Experience: 3+ years of related human subjects’ protection experience.
• Technical Skills: Knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations; Working knowledge of ethical principles related to participation of humans in research; Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review; Ability to become proficient in the use of an electronic document management system.

Skills

• Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices.
• Excellent organizational skills and professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success.
• Ability to track multiple tasks and review actions; excellent critical thinking and problem solving skills.

Benefits

Comprehensive benefits and wellness packages, 401(k) with company match, and competitive pay and paid time off.

Pay

$85,093 - $101,200

Schedule

Hybrid schedule (work 1 day onsite and remainder remote)