Senior Human Subjects Protection Scientist

Type of Requisition:

Regular

Clearance Level Must Currently Possess:

None

Clearance Level Must Be Able to Obtain:

None

Public Trust/Other

Required:

NACI (T1)

Job Family:

Science and Research

Job Qualifications:

Skills:

Human Subjects Research, IRB Protocol, IRB Submission, Research Protocols

Certifications:

None

Experience:

5 + years of related experience

US Citizenship

Required:

Yes

Job Description:

Seize your opportunity to make a personal impact as a Senior Human Su bjects Protection Scientist supporting the Office of Research and Regulatory Compliance (ORRC), Office of Human Research Oversight (OHRO) at Defense Health Agency Research & Development (DHA R&D).

The ORRC OHRO is responsible for ensuring that DHA conducted, contracted, sponsored, supported or managed research, and U.S. Army Medical Command investigations involving human subjects, human anatomical substances or animals are conducted in accordance with Federal, DoD, and international regulatory requirements.

HOW YOU WILL MAKE AN IMPACT:

• Provide regulatory-based written review of protocols using standardized checklists to ensure compliance with all applicable Federal, DoD, Food and Drug Administration (FDA), state, host nation, and DHA R&D human subjects protection requirements

• This position is tasked with reviewing research protocols that have undergone review and approval by the local Institutional Review Board (IRB); the OHRO reviewer will 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. The reviewer will work with the investigator to make updates/revisions to the materials to bring the protocol into compliance for OHRO approval

• Reviewers will be assigned a portfolio of protocols for initial review; this includes 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

• This will require active management of the assigned protocol portfolio; this includes data entry activities and use of OHRO specific information management systems to track information and activities related to protocol review

• Assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to research supported by the DHA R&D

• Assist in the development of local procedures and guidance for the OHRO and the DHA R&D in the area of human subjects' protection

• Support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines

• Assist in development and implementation of internal OHRO operating procedures and review guidelines as requested

• Foster regulatory compliance through education and training of investigators, research managers, administrators, and OHRO staff, and provide assistance to program offices and investigators with interpretation of human subjects protection and cadaver use requirements

• Acquire and retain knowledge of 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 of assigned projects

• Interact with colleagues, consultants, investigators, research directors, supervisors, other US Army personnel, etc., to gather or disseminate information or to 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 shall 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

WHAT YOU'LL NEED TO SUCCEED:

• Education:
  
  Bachelor's Degree in a scientific, or related discipline
• Required Experience:
  
  3+ years of related human subjects' protection experience
• Required 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, to allow for effective and responsible management of a caseload of research protocols submitted for DHA R&D review and oversight;
  Working knowledge of ethical principles related to participation of humans in research;
  Working knowledge of scientific research concepts and terminology to properly conduct…