Technical Human Reseach Protection Specialist Program Manager

SIERTEK LTD; Beavercreek (OH); On-site; USD 80,000 - 100,000; Full time

Job summary

SIERTEK LTD in Beavercreek, OH is looking for a Technical Program Manager for a remote role. You will oversee human research protections regulatory affairs and engage in training and administrative compliance.

The role requires substantial experience, including IRB protocol administration and a Bachelor's degree or equivalent qualifications. Familiarity with Microsoft Office applications is essential.

This position is well-suited for those with a background in Department of Defense regulatory compliance.

Qualifications

• 5+ years’ experience as a human research protections regulatory specialist.
• 2+ years in IRB protocol administration within the last 3 years.
• Proficiency in MS applications, including Word, PowerPoint, and Excel.

Responsibilities

• Provide technical review and processing of researchers' proposals.
• Analyze and evaluate research protocols for compliance.
• Host and deliver HRPP training and educational materials.

Skills

Human research protections knowledge

Regulatory compliance

Research protocol administration

Technical review

Microsoft Office proficiency

Quality assurance auditing

Education

Bachelor's Degree or equivalent

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

Location: Beavercreek, OH 45431

Position Type: Full Time

Shift: Day

SierTeK Ltd. is a minority and service‑disabled veteran‑owned company providing expertise in Program Management, Information Technology, and Administrative Support for federal Department of Defense contracts.

Job Title: Technical Program Manager

Position Overview

This is a remote position for a subject‑matter expert specialist in Department of Defense human research protections regulatory affairs.

Essential Job Functions

• Provide technical review and IRB and HRPO specific administrative processing of other researchers’ proposals, enabling independent guidance to investigators, IRB Program Director, and executive staff regarding human subjects research administration and compliance.
• Independently analyze and evaluate research protocols; coordinate and assist researchers to ensure efficient, timely processing and regulatory compliance; conduct quality assurance audits of 711 HPW/IR customers to confirm compliance.
• Apply specialized knowledge of federal and Department of Defense IRB administrative requirements, including 10 USC 980; HHS 45 CFR 46; DoD 32 CFR 219; DoDI 3216.02, AFI 40‑402; DODI 6000.08; AFRI 40‑402; and Food and Drug regulations.
• Draft e‑mail and official correspondence to facilitate the administrative and regulatory lifespan of human subject research programs.
• Develop IRB protocol templates, meeting minutes and agendas for establishing or sustaining an HRPP office.
• Plan, host and deliver HRPP training and education materials in various venues (web site, workshops, presentations, quality assurance visits) related to IRB administrative processing.
• Use a desktop computer and Microsoft Office suite along with internet applications to perform tasks in Microsoft Word, PowerPoint, Excel, and web‑based research protocol management systems; train customers on system use.
• Analyze and maintain 711 HPW/IR databases and web‑based systems for administrative management of protocols, documentation, and metrics.
• Interface with 711th Human Performance Wing (HPW), USAF Surgeon General Research Compliance (SGE‑C), and related staff/contractors to support research submissions and recommend process‑improvement solutions.
• Provide resource analysis and estimates for executing research and development projects to enhance DoD modernization needs.
• Maintain a signed NDA covering confidential, proprietary, and sensitive information; provide NDA to the Government Program Manager at the start of performance.

Qualifications

Mandatory Qualifications

• At least 5 years’ experience as a human research protections regulatory specialist within a Department of Defense (preferably Air Force) HRPP office; managing one’s own research portfolio does not meet this requirement.
• At least 2 years’ current (within past 3 years) experience in IRB protocol administration, including protocol tracking systems and technical reviews for compliance; personally conducted HRPP quality assurance audits.
• Bachelor’s Degree or equivalent (associate’s degree plus two years of related work experience, or four years of direct work experience) with competence to qualify for HRPP professional certification; current holder of CIP, CCRP, or similar preferred.
• At least 2 years’ current experience (past 3 years) in developing IRB protocol submission templates and meeting minutes/agenda for establishing or maintaining an HRPP office.
• At least 2 years’ current experience in drafting IRB or HRPO approval notices, audit result notices, non‑compliance inquiries, and related correspondence for IRB Chairpersons, Program Directors, or HRPO Officials.
• At least 2 years’ experience in developing, planning, hosting, and delivering HRPP training and education materials (web site, workshops, presentations, quality assurance visits).
• Proficiency in desktop computer applications: Microsoft Word, PowerPoint, Excel, e‑mail, web searches, electronic research, web‑page maintenance, and cloud‑based research protocol management systems.
• Experience tracking and establishing IRB protocol processing metrics and workload outcomes.

Highly Desired Qualifications

• Experience as HRPP technical expert in non‑clinical, warfighter‑centric human research regulatory compliance.
• Experience in technical review and IRB specific administrative processing of other researchers’ proposals, and in direct technical management of IRB preparation and maintenance.

Equal Opportunity Employer

SierTeK is an equal‑opportunity employer. Employment is decided based on qualifications, merit, and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, gender identity, and sexual orientation.