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20 days old

Legal Advisor/Clinical Trial Agreements Specialist - NIH

Kelly Services
Rockville, MD 20851
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 experienced individual to work as a Legal Advisor/Clinical Trial Agreements Specialist at the National Institutes of Health in Rockville, MD.


This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Vacation leave as well as 10 paid federal holidays and 401K plan.

- Access to NIHs unparalleled resources and niche scientific initiatives


TASKS/SERVICES. The contractor shall:

(1) Work closely with federal staff to develop and implement Clinical Trials Agreements (CTAs), Confidential Disclosure Agreements (CDAs), and other critical agreements with external stakeholders involved in the conduct of clinical research sponsored by the Division of AIDS.

(2) Develop recommendations for positions and solutions to resolve issues that arise involving established agreements or agreements being processed.

(3) Maintain adherence to DAIDS-wide policies, standard procedures, and guidance documents on all aspects of agreements necessary for clinical research and relevant topics.

(4) Ensure documents are in accordance with Federal Guidelines on Inherently Governmental Functions and NIH Policy on Relations with the Office of General Counsel.

(5) Provide support to staff, investigators, and collaborators on clinical research agreements, including the choice of the type of agreement to be selected and any legal/regulatory issues that arise.

(6) Collaborate with other components of NIAID and NIH including the Office of General Counsel and the NIAID Office of Technology Development (OTD) to harmonize CTA templates and provisions across various divisions of NIAID

(7) Establish methods to evaluate the effectiveness and timeliness of the development of clinical research agreements and to ensure the compliance of agreements with established requirements, standards, and procedures.

(8) Develop frequently asked questions and other informational and guidance documents derived through DAIDS experience in processing CTAs.

(9) Assist federal client in developing Memoranda of Understanding (MOU) and Interagency Agreements (IAA) to support Divisions goals.


REQUIREMENTS. The contractor must have:

(1) J.D. degree or advanced degree in a biological field (M.S. or Ph.D.).

(2) Minimum of three (3) years of clinical research regulatory affairs experience.

(3) Experience negotiating clinical trials agreements is required.


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.


Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you arent 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, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats next.


It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.


**Why Kelly** **** **?**


Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-04-23 Expires: 2021-05-24

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Legal Advisor/Clinical Trial Agreements Specialist - NIH

Kelly Services
Rockville, MD 20851

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