Research Protection Coordinator

SierTeK proudly serves our clients by providing expertise in the Program Management, Information Technology, and Administrative Support domains.

Founded in 2007 as a minority and service-disabled veteran-owned company, we serve as prime- and subcontractor for a multitude of Federal Department of Defense contracts.

By focusing on continual improvement, our services remain at the forefront of our industry, and we pride ourselves on delivering our services with the highest degree of integrity.

SierTeK Ltd. is seeking a Research Protection Coordinator to support an opportunity Remotely.

Please apply on our website at 24.13 Research Protection Coordinator (paycomonline.net)

Essential Job Functions

• Provide human subjects use research protections technical review and administrative processing of research proposals, contracts and other agreements with sufficient expertise that would enable the contractor to independently provide critical guidance to program managers, contracting officers, researchers, and human research protections officials regarding human subjects' research administration, processing, standards and regulations.
• Work within the 711 HPW / IR office and will analyze / evaluate contract proposals, statements of work, and / or research proposals seeking Department of Defense funding / awards and coordinate / assist such efforts with investigators, IRBs, AF Human Research Protection Official (HRPO) in the 711 HPW / IR office and its oversight organization at the Air Force Medical Readiness Agency (AFMRA) SGE-C, program managers, technical points of contact (TPOC), and Contracting Officers (CO) to guarantee efficient and timely human research protections compliance processing.
• Tasks shall align to ensure that prior education, training and / or experience enables the employee to be skillfully knowledgeable with federal and commercial IRB administrative requirements.
• Tasks shall be of a specialized variety and Contractor shall independently apply knowledge of and discharge timely analysis of human subjects research related to a wide-range of regulatory requirements including, but not limited to : 10 USC 980;

HHS 45 CFR 46; DoD 32 CFR 219; DoDI 3216.02 AFI 40-402; DODI 3216.01, AFRLI 40-402, as well as Food and Drug Administration (FDA) regulations and policy related to drug and medical device research.

• Tasks require high degrees of proficiency in English writing and oral communication. These capabilities, obtained through higher educational academics or experience, shall enable the employee to independently draft e-mail and official correspondence as needed to facilitate the administrative and regulatory lifespan of human subject research programs and studies.
• Be qualified to develop, plan, host and deliver HRPP training and education materials in various venues : web-site materials, workshops, training presentations, and quality assurance visits and discussions related to human research protections official administrative processing.
• Employee shall use prior knowledge, skill, training, experience to independently use a desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based / web-based research protocol management systems.

The employee shall perform tasks within an electronic web-based system and will train customers on the use of such a system.

Develop and maintain 711 HPW / IR human research protections compliance data bases and web-based systems for administrative management of tracking and documenting human research protections training, research proposal reviews, and human research HRPO approval coordination.

Minimum Position Requirements

Experience working directly, in any capacity within a Human Research Protections Program (HRPP) office, ideally within the Department of Defense (DoD).

Such experience must have included the technical review and human research protections compliance administrative processing of research proposals.

• Familiarity with HRPP administration including industry-recognized research protocol tracking systems and procedures for technical protocol reviews for administrative compliance.
• Possess a Bachelor's Degree in any discipline and experience prerequisites to be qualified to test for HRPP professional certification.
• At least 1 year of current (within the past 3 years) or prior experience in reviewing research proposals for determinations of involvement of human subjects' research, or technical qualifications (through training, experience, or certification) to conduct such reviews, or specialized research program or administrative experience that would enable contractor to become capable of conducting such reviews.
• Prior experience in independently coordinating and drafting correspondence related to human research protection official review and approval notices and other such technical correspondence for research protections officials, or other such specialized research or program management administrative experience that would enable contractor to learn and apply research protections specific requirements within one month.
• Prior experience in the development, planning, hosting and delivering HRPP training and education materials, including but not limited to web-site materials, workshops, training presentations, and quality assurance visits and discussions related to research protections compliance administrative processing and human subjects research technical and regulatory requirements.
• Possess knowledge, skill, training, experience and ability to be highly proficient in the use of desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based / web-based research protocol management systems.

SierTeK is an equal opportunity employer and values diversity. 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.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfer, leaves of absence, compensation, and training.

If you need assistance or accommodation due to a disability, you may contact us at 1+833.743.7835.