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AJANTA CONSULTING, LLC
Telework
THIS POSITION IS CONTINGENT UPON BID AWARD
The Internal Review FDA Program Manager shall provide support necessary to aid in the mission accomplishment of the U.S. Food, Drug, and Cosmetic Act and FDA regulations, policy, procedure, and guidance.
Responsibilities
Qualifications
Knowledge, Skills and Abilities
Physical Demands (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Teleworking Permitted?
Yes
Teleworking Details
100% Telework
Estimated Salary/Wage
USD $77,000.00/Yr. Up to USD $190,000.00/Yr.
AJANTA CONSULTING, LLC
Telework
THIS POSITION IS CONTINGENT UPON BID AWARD
The Internal Review FDA Program Manager shall provide support necessary to aid in the mission accomplishment of the U.S. Food, Drug, and Cosmetic Act and FDA regulations, policy, procedure, and guidance.
Responsibilities
- 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.
- 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.
- 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 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: web-site materials, workshops, training presentations, and 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 IR leadership is kept current on the progress of the program.
- Serve as the primary contact with the FDA in the review, analysis, and response to FDA communications by regulatory deadlines.
- Perform tasks for 711 HPW/IR within an electronic web-based system and shall train customers on the use of such a system.
- Analyze and maintain 711 HPW/IR data bases 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.
- Interface with the following staff offices.
- 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.
- Other duties as assigned
Qualifications
- Minimum Bachelor's Degree
- Minimum one (1) year, within the past three (3) years, experience in IRB protocol administration including industry recognized protocol tracking systems, technical protocol reviews for administrative compliance, and shall have personally conducted HRPP quality assurance audits of customer's research projects.
- Minimum one (1) year, within the past three (3) years, experience in developing IRB protocol templates and protocol templates related to FDA-regulated research activities and clinical trials
- Minimum one (1) year, within the past three (3) years, experience working and communicating with the FDA for pre-submission consultations.
- Minimum one (1) year, within the past three (3) years, developing regulatory strategies for diverse medical products.
- Possess a current HRPP Professional Certification Preferred
Knowledge, Skills and Abilities
- Experience in independently drafting IRB approval notices, audit result notices, , and other such IRB related technical correspondence for IRB Chairpersons and IRB Program Directors.
- 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, and Principal Investigator and Sponsor responsibilities, web-site materials, workshops, training presentations, and quality assurance visits and discussions related to IRB and FDA administrative processing.
- Experience within the last two (2) years in any capacity within a Human Research Protection Program (HRPP) office
- Experience within the last two (2) years of preparing one's own research proposals and one's own submissions to an Institutional Review Board (IRB) or to the U.S. Food and Drug Administration and managing one's own research portfolio will not meet the qualifications required by this section.
- 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.
- Knowledgeable with federal, FDA, and Department of Defense IRB administrative requirements
- Knowledge of and discharge timely analysis of human subject's research related to a wide range of regulatory requirements
- 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.
- Experience in conducing complex analysis 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.
- Possess knowledge and proficiency in English writing and oral communication.
- Experience working directly for a Department of Defense HRPP or the U.S. FDA Preferred
- Experience in 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 Preferred
Physical Demands (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
- Required to travel when authorized to participate in customer business line related travel, to include meetings and conferences, to fulfill respective mission goals.
- While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee may use repeated motions that include the arms, wrists, hands and/or fingers. The employee is occasionally required to walk, stand, climb, balance, stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.
Teleworking Permitted?
Yes
Teleworking Details
100% Telework
Estimated Salary/Wage
USD $77,000.00/Yr. Up to USD $190,000.00/Yr.
