Human Research Protection Scientist

General Dynamics Information Technology, Inc.; Frederick (MD); Hybrid; USD 64,000 - 86,000; Full time

Job summary

General Dynamics Information Technology, Inc. seeks a Human Research Protection Scientist to oversee DHA-supported research protocols, ensuring regulatory compliance across federal and DoD requirements.

The role demands 2+ years of related experience, a Bachelor’s in a scientific field, and proficiency with Microsoft Office and electronic review systems. Arbeiten in a hybrid Ft. Detrick setting with occasional travel.

Qualifications

• Bachelor’s degree in a scientific or related discipline.
• 2+ years of human subjects protection experience.
• Proficiency with Microsoft Office Suite and electronic document management/review systems.

Responsibilities

• Provide real-time oversight of DHA-supported research protocols to ensure compliance with federal, DoD, FDA, Army, and DHA requirements.
• Deliver regulatory-based written reviews and evaluations of protocol lifecycle actions using standard checklists.
• Identify deficiencies and advise OHRO authorities on regulatory and ethical issues in post-approval submissions.
• Assist with planning, data entry, and management of protocol files and OHRO information systems.

Skills

Code of Federal Regulations

Communication

Ethical Practices

Human Subjects Research

Microsoft Office

Education

Bachelor’s Degree in a scientific, or related discipline

Job description

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: Code of Federal Regulations, Communication, Ethical Practices, Human Subjects Research, Microsoft Office Certifications: None Experience: 2 + years of related experience US Citizenship Required: Yes 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).

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 make 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 #GDITFedHealthJobs #GDITHealth

The likely salary range for this position is $64,230 - $86,250. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Scheduled Weekly Hours: 40 Travel Required: 10-25% Telecommuting Options: Hybrid Work Location: USA MD Fort Detrick Additional Work Locations:

Total Rewards at GDIT

• Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match.
• To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave.
• To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available.
• We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.

Our Identity Verification Process: As part of the hiring process, we will ask you to complete an identity verification process that leverages advanced biometrics and artificial intelligence to ensure authenticity and protect against identity fraud. You are expected to be on camera during virtual interviews. We reserve the right to take your picture to verify your identity and prevent fraud. By proceeding, you authorize the collection, processing, and use of your biometric data for identity verification and security purposes.

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