Program Manager - Institutional Review FDA

Company: Knowesis Inc.
Location: Fairfax
Posted on: May 27, 2023

Job Description:

Position: Program Manager - Institutional Review FDA

Location: Remote

Salary Range: $65,000 - $90,000

Knowesis is seeking an Institutional Review Federal Drug Administration Program Manager who will provide technical review and IRB-specific administrative processing of others' research proposals. The IR FDA Program Manager will guide researchers, IRB Program Director, and executive staff regarding human subject research and FDA-regulated activities administration, processing, standards, and regulations.

This position requires a Position of Trust and U.S. Citizenship (applicants without proof of U.S. citizenship will not be considered due to the position's security clearance requirement).

The Job Duties and Responsibilities include but are not limited to the following:

* Provide technical review and IRB-specific administrative processing 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, and FDA-regulated activities administration, processing, standards, and regulations.
* 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 skillfully knowledgeable with federal, FDA, 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; 21 CFR, 24, CFR 219; DoDI 3216.02_AFI 40-402; DODI 6000.08, AFRLI 40-402, as well as Food and Drug Administration (FDA) policy and guidance documents 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.
* Develop IRB protocol templates, meeting minutes, and agenda for establishing or continuous function of an HRPP office.
* Develop, plan, host, and deliver HRPP training and education materials in various venues: website materials, workshops, training presentations, quality assurance visits, and discussions related to IRB administrative processing and HRPP.
* Provide subject matter expertise on all FDA regulatory matters related to assigned FDA projects and ensure I.R. leadership is kept current on the program's progress.
* Serve as the primary contact with the FDA in the review, analysis, and response to FDA communications by regulatory deadlines.
* Use prior knowledge, skill, training, and experience to independently use a desktop computer workstation for the accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, and Excel, as well as internet applications, including e-mail, worldwide web searches, electronic-based research, web-page maintenance, and cloud-based/web-based research protocol management systems. The Contractor shall perform 711 HPW/IR tasks within an electronic web-based system and train customers on using such a system.
* Analyze and maintain 711 HPW/IR databases and web-based systems for administrative management of research protocols, protocol-related documentation/information management, and research protocol metrics for protocol processing and time management.
* The IR FDA PM must have an exceptionally high capacity for working autonomously and performing assigned tasks with minimal supervision and shall have demonstrated competency and effectiveness in working with inter-professional teams.


* Possess the ability to effectively collaborate and communicate with research colleagues, medical professionals, DoD employees, government officials, and civilian researchers in academic and clinical settings on research execution and translation.



Required Qualifications:

* Minimum of at least two years experience in any capacity within a Human Research Protection Program (HRPP) office. Work in preparing one's research proposals and submissions to an Institutional Review Board (IRB) or the U.S. Food and Drug Administration and managing one's research portfolio will not meet the qualifications required by this section.
* One year (within the past three years) of personal and direct experience in IRB protocol administration, including industry-recognized protocol tracking systems and technical protocol reviews for administrative compliance, and shall have personally conducted HRPP quality assurance audits of customers' research projects.
* Bachelor's Degree or equivalency, journeyman-level knowledge of U.S. Food, Drug and Cosmetic Act and FDA regulations, policy, procedure, and guidance, and meet all technical and experience prerequisites to be qualified to test for HRPP professional certification, such as Regulatory Affairs Certification (RAC), Certified Clinical Research Professional (CCRP) or other like-kind industry-standard certification. The current holder of HRPP professional certification is preferred.
* One year of current (within the past three years) prior experience in developing IRB protocol templates and protocol templates related to FDA-regulated research activities and clinical trials.
* Prior experience independently drafting IRB approval notices, audit result notices, and other such IRB-related technical correspondence for IRB Chairpersons and IRB Program Directors.
* Prior experience in the development, planning, hosting, and delivering HRPP, training, and education materials, including but not limited to information and didactic material on FDA regulations, guidance, submission processes, Principal Investigator and Sponsor responsibilities, website materials, workshops, training presentations, and quality assurance visits and discussions related to IRB and FDA administrative processing.
* Knowledge, skill, training, experience, and ability to be highly proficient in the use of desktop computer workstation for the accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, and Excel, as well as internet applications including e-mail, worldwide web searches, electronic-based research, web-page maintenance, and cloud-based/web-based research protocol management systems.
* Prior experience in conducting complex analyses of FDA-regulated drug and device research proposals, as well as experience in the development and submission of experimental drug and device applications to the FDA.
* Minimum one year in the past three years of experience working and communicating with the FDA for pre-submission consultations.
* Minimum one year in the past three years spent developing regulatory strategies for various medical products.

Preferred Qualifications:

* Certified IRB Professional (CIP)
* Experience working directly for a Department of Defense HRPP or the U.S. FDA
* Experience ideally shall include the technical review and IRB-specific administrative processing of others' FDA-regulated experimental drug and device research proposals and submission to the FDA for 510(k), De Novo, and Investigational Device Exemption (IDE applications to the FDA

Minimum Years of Detailed Experience:

* Two years experience in any capacity within a Human Research Protection Program (HRPP) office.
* One year (within the past three years) of personal and direct experience in IRB protocol administration, including industry-recognized protocol tracking systems and technical protocol reviews for administrative compliance, and shall have personally conducted HRPP quality assurance audits of customers' research projects.
* At least one year of current (within the past three years) prior experience in developing IRB protocol templates and protocol templates related to FDA-regulated research activities and clinical trials.
* At least one year in the past three years of experience working and communicating with the FDA for pre-submission consultations.
* At least one year in the past three years spent developing regulatory strategies for various medical products.

Required Education:

* Bachelor's Degree or equivalency

Knowesis is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Keywords: Knowesis Inc., Washington DC , Program Manager - Institutional Review FDA, Executive , Fairfax, DC