Description
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an individual for a short-term project (estimated 1-2 months until late May 2025) to work as a Clinical Protocol Specialist at the National Institutes of Health (NIH) in Bethesda, MD.
TASKS/SERVICES. The contractor shall:
(1) Provide regulatory guidance and assistance for protocol development, implementation, and continuing support for National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intramural research protocols.
(2) Serve as the point-of-contact and project manager for an assigned portfolio of projects.
(3) Work with PIs and the research team on the design, plan, production and revision of
study documents, including applying clinical and regulatory knowledge to the review of
protocol and informed consent documents.
(4) Work with research staff to navigate requirements for protocol approval and continued conduct, which may include completing submissions to approving bodies (e.g., scientific review, IRB and radiation safety), coordinating with PIs and the research team to ensure stipulations are addressed appropriately, and tracking the required approvals necessary to initiate and continue intramural research.
(5) Prepare other program actions that do not go to the IRB such as data sharing plans, reliance agreements and technology transfer agreements.
(6) Provide advice and assistance in troubleshooting human subjects protection issues.
(7) Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments
(8) Work with the Office of Human Subjects Research Protection (OHSRP) to keep abreast of new guidance related to policy governing the conduct of research at the NIH Intramural Research Program
(9) Maintain regulatory files, ensure protocol design safety issues are identified early, and required oversight is initiated as outlined in the protocol.
(10) Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.
(11) Disseminate expertise and best practices related to human subjects protections in clinical research through presentations, publications, and/or interactions with colleagues.
REQUIREMENTS. The contractor ideally would have:
(1) Master's degree related to life science, public health or healthcare; three (3) years of specialized experience plus a bachelor's degree is equivalent to a master's degree
(2) Relevant clinical research experience to serve as an expert and program manager for principal investigators and other staff responsible for planning, developing, approving, implementing, and tracking research protocols
(3) Regulatory experience including mastery of the IRB process and the submission/approval process
(4) Ability to work in a clinical research regulatory setting, both independently and with a team, to coordinate, negotiate and facilitate program goals, mitigate potential problems, move projects forward expeditiously, and meet deadlines
PLEASE APPLY ONLINE
When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren't contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.
As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kelly's Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what's next.
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Government Solutions?
Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the world's most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It's just another way we make the job search work for you.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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