Human Research Protection Scientist

General Dynamics Information Technology•Fort Detrick, MD

2d•$64,230 - $86,250•Hybrid

About The Position

The Human Research Protection Scientist supports the Office of Research and Regulatory Compliance (ORRC), Office of Human Research Oversight (OHRO), at Defense Health Agency Research & Development. The role provides real-time oversight of DHA-supported research protocols and helps ensure research involving human subjects, human anatomical substances, or animals complies with applicable Federal, DoD, FDA, Army, state, host-nation, and DHA requirements. The position conducts documented regulatory reviews of protocol lifecycle actions, identifies deficiencies and potential noncompliance, and makes recommendations to federal approval authorities. It also supports compliance investigations, inspections, staff assistance visits, and human research protection program assessments. The scientist helps prepare inspection and visit materials and reports, contributes to policies, procedures, guidance, and training, and provides regulatory and ethical research guidance to investigators, research staff, and OHRO personnel. The role is based at Fort Detrick, Maryland, on a hybrid schedule with two days onsite and the remainder remote. Staff are expected to be accessible during core hours of 9 a.m. to 3 p.m., with flexibility to set other hours around those core hours. Travel is minimal as needed to support oversight activities; the posting lists travel required as 10–25%.

Requirements

Bachelor’s degree in a scientific or related discipline, or an equivalent combination of education, professional training, or work experience.
At least 2 years of related human subjects protection experience.
Working knowledge of Federal regulations governing protection of human research participants.
Working knowledge of ethical principles related to human participation in research.
Working knowledge of scientific research concepts and terminology sufficient to conduct detailed analyses of research protocols.
Ability, following training and guidance, to become expert in applying human research protection regulations, policies, and guidelines.
Proficiency with Microsoft Office Suite.
Ability to become proficient with an electronic document management and review system.
Excellent organizational skills, professional conduct, and a businesslike manner.
Meticulous attention to detail and commitment to team success.
Ability to communicate effectively with researchers, research staff, and IRB members about compliance and ethical human research practices.
Strong critical-thinking and problem-solving skills, including identifying issues and developing solutions.
U.S. citizenship.
Clearable for a NACI (T1) security investigation.

Nice To Haves

Experience managing or supporting clinical research.
Experience working in or supporting an Institutional Review Board.

Responsibilities

Provide timely, documented oversight reviews of DHA-supported research protocol lifecycle actions to assess compliance with applicable requirements.
Review continuing reviews, amendments or modifications, and closures using standardized checklists and guidance materials.
Identify deficiencies and areas of noncompliance and recommend actions to OHRO federal approval authorities on regulatory and ethical issues.
Manage an assigned protocol portfolio, provide information and documents to customers and federal personnel, enter data, maintain protocol files, and update tracking and information management systems.
Support noncompliance investigations and compliance inspections of extramural protocols.
Help prepare written compliance inspection reports that document findings and recommend steps for bringing research into compliance.
Support staff assistance visits and human research protection program assessments, including planning, agendas, materials, and educational presentations.
Participate in interviews with investigators, study staff, IRB staff, institutional officials, and research participants; review records and policies; complete checklists; and help prepare after-action reports.
Travel to sites as needed to support compliance oversight of DHA-supported research studies.
Assist the Government in developing and updating policies, procedures, guidelines, and other human research protection and regulatory compliance materials.
Help develop local OHRO and DHA procedures and guidance, and mechanisms to communicate and interpret regulations and policies.
Assist with internal OHRO operating procedures and review guidelines.
Promote regulatory compliance through education and training and assist program offices and investigators with interpreting human research protection and cadaver-use requirements.
Maintain and apply knowledge of current applicable regulations and ethical principles when reviewing assigned projects.
Communicate with colleagues, consultants, investigators, research directors, supervisors, and other Army personnel; attend meetings and conference calls and provide education on applicable requirements.
Participate in performance improvement activities and working groups to improve protocol review and approval processes, and contribute to OHRO standard operating procedures and work instructions.

Benefits

Comprehensive benefits and wellness packages.
401(k) with company match.
Competitive pay and paid time off.
Medical plan options, including some with Health Savings Accounts.
Dental plan options.
Vision plan.
Full flex work weeks where possible.
Paid time off plans including vacation, sick and personal time, holidays, paid parental, military, bereavement, and jury duty leave.
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.
Career growth tool identifying career steps and learning opportunities.
Internal mobility team focused on career goals.