24-9 Regulatory Affairs Specialist

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 Regulatory Affairs Specialist to support an opportunity remotely.

POSITION OVERVIEW

This position is for a part-time subject matter expert specialist Food and Drug Administration (FDA) Regulatory Affairs.

Essential Job Functions

• Employee shall provide expert technical research FDA-related regulatory review of others’ research proposals and be of the kind and sufficient experience that would enable the contractor to independently provide critical guidance to researchers, IRB Program Director, and executive staff regarding human subject research administration, processing, standards and regulations.
• Employee shall independently analyze/evaluate research protocols and coordinate/assist investigators’ efforts to guarantee efficient and timely processing of protocols and regulatory compliance and to conduct quality assurance audits of AFRL customers to confirm such regulatory compliance.
• Tasks shall align to ensure that prior education, training and/or experience enables the Contractor to be knowledgeable with federal and Department of Defense 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 6000.08, AFRLI 40-402, as well as 21 CFR, Food, Drug and Cosmetic Act (FD&C Act) and Food and Drug Administration (FDA) regulations and policy related to drug and 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 Contractor to independently draft e-mail and official correspondence as needed to facilitate the administrative and regulatory lifespan of human subject research programs and studies.
• Employee shall develop, plan, host and deliver FDA research Regulatory Affairs training and education materials in various venues: web-site materials, workshops, training presentations, and quality assurance visits and discussions related to FDA regulatory requirements for researcher data controls.
• 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 Contractor shall perform tasks for 711 HPW/IR within an electronic web-based system and shall train customers on the use of such a system.
• Employee shall interface with the following staff offices: 711th Human Performance Wing (HPW) (USAFSAM and RH), USAF Surgeon General Research Compliance (SGE-C), U.S. Food and Drug Administration (FDA), and their respective related staff/contractors, and other diverse research collaborators.

Mandatory Qualifications

• Employee shall have at least 5 years' experience applying FDA research regulatory requirements within a research Regulatory Affairs program office. Work in preparing one’s own research proposals and one’s own submissions to an IRB office or to the FDA and managing one’s own research portfolio will not meet the qualifications required by this section.
• 3-year current (within the past 5 years) personal and direct experience in FDA clinical research protocol compliance administration and shall have personally conducted FDA focused Regulatory Affairs quality assurance audits of customer’s research projects.
• Possess a 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 that would provide the experience, knowledge and skills that are needed to perform the work proficiently. Will meet all technical and experience prerequisites to be qualified to test for Regulatory Affairs Professional certification, such as Certified Clinical Research Professional (CCRP), Research Regulatory Affairs Professional (RAP) or other like-kind industry standard certification. Current holder of Regulatory Affairs professional certification is preferred.2 years current (within the past 3 years) or prior experience in developing IRB protocol submission templates and IRB meeting minutes and agenda for establishment of or continued function of a HRPP office.
• At least 1 year current (within the past 3 years) prior experience in developing or providing detailed consultation on the development of FDA-regulated clinical drug or device research trials, including, but not limited to research involving software as a medical device (SoMD) and off-label research use of FDA-controlled medical devices.
• Employee shall have prior experience in independently drafting FDA research Regulatory Affairs implementation guidance.
• Employee shall have prior experience in the development, planning, hosting and delivering FDA research Regulatory Affairs training and education materials, including but not limited to web-site materials, workshops, training presentations, and quality assurance visits and discussions related to administration of clinical trial research records.
• Employee shall have knowledge, skill, training, experience and ability to be 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.
• Employee shall have knowledge or experience in human research protections and institutional review board (IRB) ethical and regulatory matters.
• Employee shall have a signed Non-Disclosure Agreement (NDA) in place with their company based on the potential access to confidential, proprietary, and/or sensitive information. NDA shall be provided to the Government Program Manager by start of performance.

Highly Desired Qualifications

• Experience working directly for a Department of Defense research Regulatory Affairs program office.
• Experience shall include the technical review and FDA research compliance review of non-clinical warfighter operational health and performance biosensing and human wearable bio-devices.

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.