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Form of workProgram Manager
Are you a Program Manager who loves solving complex problems?
Do you have a keen eye for detail and excellent analytical skills?
Would your friends describe you as a self-starter who takes pride in your work and enjoys collaborating with others?
If so, we have an exciting opportunity for you at The Greentree Group!
WHO WE ARE
The Greentree Group is a dynamic, innovative, and thriving company that specializes in delivering advanced technology solutions to federal, state, and commercial clients. With a team of highly skilled professionals, we provide cutting-edge services and are always pushing the boundaries of what’s possible.
What sets us apart is our commitment to excellence and our passion for the work we do. At The Greentree Group, we are driven by a shared sense of purpose and a desire to make a difference in the lives of people around us. Whether it's helping our clients achieve their goals, developing innovative solutions to complex problems, or giving back to the community, we are dedicated to making a positive impact.
We also believe in investing in our people and providing them with opportunities for growth, development, and advancement. We offer a dynamic and supportive work environment, a culture of continuous learning, and a wide range of benefits and perks that promote work-life balance and personal well-being.
Whether you're a seasoned expert or just starting out in your career, if you're passionate about technology, committed to excellence, and eager to take on new challenges, we want to hear from you!
ABOUT THE OPPORTUNITY
As a potential Program Manager, you will have the opportunity to work with cutting-edge technologies and collaborate with a talented team of professionals at Wright-Patterson Air Force Base. This potential role will be critical in ensuring Institutional Review Board (IRB) protocol administration in support of the 711th Human Performance Wing, the Airman Systems Directorate (RH), and the United States Air Force School of Aerospace Medicine (USAFSAM). Join us and be part of our mission to make a difference!
SOME RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
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.
Skillfully knowledgeable with federal, FDA, and Department of Defense IRB administrative requirements. 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.
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.
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.
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.
MINIMUM QUALIFICATIONS:
2 years’ experience in any capacity within a Human Research Protection Program (HRPP) office. Work in 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.
1 year of current (within the past 3 years) of personal and direct 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.
A 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. Current holder of HRPP professional certification is preferred.
1 year of current (within the past 3 years) experience in developing IRB protocol templates and protocol templates related to FDA-regulated research activities and clinical trials.
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.
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.
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.
1 year of current (within the past 3 years) experience working and communicating with the FDA for pre-submission consultations.
1 year of current (within the past 3 years) developing regulatory strategies for diverse medical products.
Candidates must be U.S. Citizens and have the ability to pass a National Agency Check Investigation conducted by the US Federal Government.
Have a signed Non-Disclosure Agreement (NDA) in place with their company based on the potential access to confidential, proprietary, and/or sensitive information.
DESIRED QUALIFICATIONS:
Experience working directly for a Department of Defense HRPP or the U.S. FDA.
Experience with 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.
We believe in fostering a positive, inclusive culture that values diversity, teamwork, and personal growth. With opportunities for advancement and a supportive community of colleagues, The Greentree Group is the perfect place to build your career. Learn more about us at www.greentreegroup.com. Please note that this role may require a National Agency Check (NAC) and/or background check, and relocation assistance is not available at this time.
Greentree is an Equal Opportunity Employer and does not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, or status as a qualified individual with a disability or protected veteran.
Compensation / Salary Range: Greentree adheres to federal, state, and local regulations. This is a Full-Time, Salary, Exempt position. The following salary range is what we reasonably expect to pay but is contingent and subject to a variety of factors, including but not limited to years of experience, education, certification(s), training, specialized skills, responsibilities, etc.
Bonuses: Greentree has an employee referral bonus, as well as employee bonuses based on employee contributions and Greentree’s yearly performance.
Top Benefits
Core Benefits 100% paid by Greentree: Employee Medical Premium on the High Deductible Health Plan (HDHP), Basic Life Insurance and AD&D, Short-Term Disability (STD), Long-Term Disability (LTD), Health Reimbursement Account (HRA), 401(k) Match, Job-Related Certifications, and Training Programs
Elected Benefits: Medical, Dental, Vision, HSA, FSA, Voluntary Term Life, 401(k) (Roth and Pretax available)
Time Off: PTO, Flexible Schedules, Holidays and Paid Parental Leave: Work-life balance is important – we all enjoy some time off for rest and relaxation! Employees receive a very generous amount of PTO which is granted on start date, plus the ability for quick escalation to the next tier. Flexible/hybrid working schedules and 11 paid holidays, in addition to paid parental leave round out the work-life balance benefits.
Paid Training and Development: We encourage and support ongoing employee learning and development, consistent with needs of the company, its clients, and markets. Greentree is committed to paying the cost for job-related certifications and/or training programs. In conjunction with management/employee communication and discussions regarding performance and goals, employees are expected to seek out and pursue development opportunities to meet emerging organizational skill requirements in combination with their own personal growth needs. Greentree also makes job-related tuition reimbursement contributions for those in higher-level education programs.
