Senior Human Subjects Protection Scientist

General Dynamics Information Technology; Frederick (MD); Hybrid; USD 85,000 - 101,000; Full time

Benefits offered by this job

Hybrid schedule

Total rewards benefits

Job summary

General Dynamics Information Technology (GDIT) seeks an experienced Senior Human Subjects Protection Scientist to support the ORRC/OHRO within DHA R&D. The role ensures DHA-conducted and sponsored research complies with Federal, DoD, FDA, and international requirements.

The candidate will review protocols, identify regulatory deficiencies, and advise investigators and administrators. Hybrid work, strong regulatory expertise, and 9–5 core hours are expected.

Qualifications

• Bachelor’s degree in a scientific or related discipline is required.
• Knowledge of the Federal regulations governing human subjects protections (Common Rule, FDA).
• Experience reviewing and editing DHA R&D protocol submissions for OHRO review.
• Ability to apply DoD and DHA R&D human subjects protections policies.
• Strong organizational skills and attention to detail.

Responsibilities

• Provide regulatory-based written review of protocols using checklists.
• Identify deficiencies and regulatory noncompliance in OHRO submissions.
• Delineate issues and make recommendations to OHRO authorities.
• Work with investigators to update materials for OHRO approval.
• Manage portfolio of protocols, including data entry in OHRO systems.
• Develop and update local procedures and guidance on human subjects protection.

Skills

Human Subjects Research

IRB Protocol

IRB Submission

Research Protocols

Education

Bachelor’s Degree in a scientific or related discipline

Tools

Microsoft Office Suite

Job description

Job Qualifications:
Human Subjects Research, IRB Protocol, IRB Submission, Research Protocols

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
Skills:
Job Qualifications:
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 Subjects 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 detailed analyses of all research protocols submitted for IRB review; Following individual training and guidance, ability to become expert at applying DoD, and DHA R&D human subjects protection regulations, policies and guidelines; Proficiency with Microsoft Office Suite
• Attributes for Success: Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices; Possess excellent organizational skills and professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success; Ability to track multiple tasks and review actions; excellent critical thinking and problem solving skills
• Preferred Skills: 5 + years experience; Ability to become proficient in the use of an electronic document management system
• Location: Ft Detrick (Frederick, Maryland) Hybrid schedule (work 2 days onsite and remainder remote)
• Work Hours: 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 $85,093 - $101,200. 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

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.

About Our Work:
We are GDIT. A global technology and professional services company that delivers technology solutions and mission services to every major agency across the U.S. government, defense and intelligence community. Our 26,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50+ countries worldwide, offering leading mission-ready capabilities in AI, cloud, cyber and software development.

Join our Talent Community to stay up to date on our career opportunities and events at
gdit.com/tc.

Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans