Technical Human Research Protection Specialist Program Manager

Role Description

SierTeK Ltd. is seeking a Technical Program Manager to support an opportunity remotely. This position is for a subject matter expert specialist in Department of Defense human research protections regulatory affairs.

• Provide technical review and IRB and HRPO specific administrative processing of others’ research proposals.
• Independently analyze/evaluate research protocols and coordinate/assist investigators’ efforts to guarantee efficient, timely processing of protocols and regulatory compliance.
• Conduct quality assurance audits of 711 HPW/IR customers to confirm regulatory compliance.
• Tasks shall align to ensure that prior education, training and/or experience enables the Contractor to be skillfully knowledgeable with federal and Department of Defense IRB administrative requirements.
• Tasks require proficiency in English writing and oral communication.
• Develop IRB protocol templates and IRB meeting minutes and agenda for establishment of or continued function of a HRPP office.
• Develop, plan, host and deliver HRPP training and education materials in various venues.
• Use prior knowledge, skill, training, experience to independently use a desktop computer workstation for accomplishment of tasks.
• Analyze and maintain 711 HPW/IR databases and web-based systems for administrative management of research protocols.
• Interface with various staff offices to further administrative processing of human subjects' research submissions.

Qualifications

• At least 5 years' experience as a human research protections regulatory specialist within a Department of Defense (preferably Air Force) human research protections program (HRPP) office.
• 2 years current (within the past 3 years) personal and direct experience in IRB protocol administration.
• Bachelor’s Degree or Associate’s Degree/two years of college plus 2 years of related work experience or 4 years of direct work experience in the field.
• 2 years current (within the past 3 years) or prior experience in developing IRB protocol submission templates.
• 2 years current (within the past 3 years) experience in independently drafting IRB or HRPO approval notices.
• 2 years current (within the past 3 years) prior experience in the development, planning, hosting and delivering HRPP training and education materials.
• Knowledge, skill, training, experience and ability to be proficient in the use of desktop computer workstation.
• Prior experience in tracking and establishing IRB protocol processing metrics and workload outcomes.
• Have a signed Non-Disclosure Agreement (NDA) in place with their company.

Requirements

• Current holder of HRPP professional certification is preferred.

Benefits

• 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.