Human Research Protection Scientist

General Dynamics Information Technology, Inc.; Maryland; Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Growth opportunities

Internal mobility

Competitive benefits

Military-friendly culture

Job summary

General Dynamics Information Technology, Inc. seeks a Human Research Protection Scientist to oversee DHA-supported research protocols for regulatory and ethical compliance.

You will perform ongoing reviews, draft evaluations, and assist in inspections and training. Domestic travel is possible; a combined onsite/remote schedule is expected. A bachelor’s degree in a scientific field and knowledge of federal regulations are required.

Qualifications

• Knowledge of Federal regulations governing protection of human research participants.
• Understanding of ethical principles in human subjects research.
• Ability to analyze research protocols and perform detailed regulatory reviews.
• Proficiency with Microsoft Office Suite and related tools.
• Ability to learn OHRO review systems and procedures

Responsibilities

• Provide real-time oversight of DHA-supported research protocols with timely reviews.
• Conduct regulatory-based written reviews of protocol lifecycle actions.
• Identify deficiencies and advise OHRO authorities on regulatory issues.
• Manage protocol portfolio, data entry, and information tracking systems.
• Support noncompliance investigations and compliance inspections.
• Assist in preparing written reports of inspections and findings.
• Develop staff materials and participate in OHRO policy guidance.
• Travel to sites as needed to support OHRO personnel

Skills

Regulatory knowledge

Ethical principles

Research concepts

Office software

Electronic document management

Education

Bachelor’s Degree in a scientific or related 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
• Preferred Skills:Preference given to applicants with experience managing or supporting clinical research, or have experience working in/support an Institutional Review Board;

• 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:

At GDIT, the mission is our purpose, and our people are at the center of everything we do.

• Growth: AI-powered career tool that identifies career steps and learning opportunities
• Support: An internal mobility team focused on helping you achieve your career goals
• Rewards: Comprehensive benefits and wellness packages, 401K with company match, and competitive pay and paid time off
• Community: Award-winning culture of innovation and a military-friendly workplace

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