Human Research Protection Scientist

General Dynamics Information Technology; Frederick (MD); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

AI-powered career tool

Internal mobility team

Comprehensive benefits and wellness

401K with company match

Paid time off

Job summary

General Dynamics Information Technology is seeking a Human Research Protection Scientist to support the Office of Research and Regulatory Compliance. You will oversee DHA-supported research protocols, perform regulatory reviews, and help ensure compliance with Federal, DoD, FDA, Army, and host nation requirements.

Qualifications include a Bachelor’s Degree in a scientific field and 2+ years of related human subjects protection experience, with strong communication and documentation skills.

Qualifications

• Strong understanding of Federal regulations governing human subjects protection.
• Ability to conduct detailed analyses of research protocols submitted for review.
• Proficiency with Microsoft Office Suite and related tools.

Responsibilities

• Provide real-time oversight of DHA-supported research protocols with timely reviews.
• Evaluate protocol lifecycle actions using standardized checklists.
• Identify deficiencies and advise OHRO authorities on regulatory/ethical issues.
• Manage protocol portfolio including data entry and updating files.
• Assist in noncompliance investigations and inspections of extramural protocols.
• Prepare written reports of compliance inspections with findings and recommendations.
• Support staff during OHRO visits with planning, agendas, and materials.
• Participate in interviews and conduct detailed regulatory record reviews.

Skills

Federal regulations knowledge

Ethical principles

Research protocol analysis

Documentation management

Education

Bachelor’s Degree in a scientific discipline

Tools

Electronic document management system

Job description

Seize your opportunity to make a personal impact as a Human Research 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 real-time oversight of DHA-supported research protocols through timely documented reviews of protocol lifecycle actions to ensure ongoing compliance with all applicable Federal, DoD, Food and Drug Administration (FDA), Department of the Army (DA), state, host nation, and DHA human research protection regulatory requirements.

• Provide regulatory-based written review and a comprehensive evaluation of protocol life cycle actions (continuing review, amendments/modifications, closures) using standardized checklists and guidance materials.

• Delineate deficiencies and areas of noncompliance and makes recommendations to the OHRO federal approval authorities regarding regulatory and ethical issues in OHRO post-approval submissions.

• 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 and updating the protocol files and the information management systems used to track information and activities related to protocol review.

• Support the OHRO federal personnel in the conduct of noncompliance investigations and compliance inspections of extramural protocols.

• Assist in the preparation of the written report of each compliance inspection that includes, but is not limited to, documentation/ presentation of specific findings of the inspection and recommendations that would enable the institution to bring the research into compliance.

• Provide support for staff assistance visits and HRPP assessments designed to monitor compliance with human research protection regulations and make recommendations for improvement. This includes assisting with planning, formulation of agenda and preparation of materials for use during the visit, to include any educational presentations.

• Prepare staff assistance visit materials (e.g. agenda, checklists, presentation).

• Participate in interviews with investigators, study staff, IRB staff, institutional officials, and research participants, and conduct detailed policy and regulatory record reviews, complete staff assistance checklists, and assist with preparation of after-action reports.

• Travel to sites, as needed, to support OHRO Federal personnel to provide compliance oversight to DHA-supported research studies. Note that travel is minimal.

• 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 research protection and regulatory compliance policies and procedures as they apply to research supported by the DHA.

• Assist in the development of local procedures and guidance for the OHRO and the DHA in the area of human research 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 research protection and cadaver use requirements.

• Acquire and retain knowledge of current Federal, DoD, FDA, Army, state, host nation, and USAMRDC regulatory requirements related to the protection of human participants 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 research protection regulations and OHRO requirements.

• Participate in performance improvement activities and 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: 2+ years of related human subjects’ protection experience
• Required Technical Skills: Working knowledge of the Federal regulations governing the protection of human research participants; 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 review; Following individual training and guidance, ability to become expert at applying human research protection regulations, policies and guidelines; Proficiency with Microsoft Office Suite; Ability to become proficient in the use of an electronic document management and review system
• Attributes for Success: Excellent organizational skills, professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success; Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices; Excellent critical thinking and problem-solving skills with ability to identify issues/problems as well as develop solutions

• Location: Ft Detrick (Frederick, Maryland) Hybrid schedule (work 2 days onsite and remainder remote)

• Work Hours: Specific on-site days are assigned by Program Manager. Staff are expected to be accessible during core hours of 9AM to 3PM, but have flexibility to set their schedule around those core hours.

• US citizenship required

• Security Clearance: Clearable for a NACI (T1) security investigation

GDIT IS YOUR PLACE:

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