30 days old

Human Subjects Protection Specialist - NIH - Rockville, MD

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 Human Subjects Protection 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) Provide human subject protections related advice and guidance on protocols and associated documents

(2) Participate in Prevention/Clinical Science Review Committees and full regulatory reviews as applicable and provide advice on human subject protections-related aspects of the protocol under review.

(3) Provide advice on human subject protections-related aspects of the protocol and related documents throughout the lifecycle of the protocol.

(4) Possess and maintain knowledge of pertinent human subject protections regulations including Office for Human Research Protections (OHRP), Food and Drug Administration (FDA) regulations, and ICH guidelines.

(5) Contribute to and participate in inspection preparedness activities

(6) Maintain up-to-date knowledge of regulatory and policy changes including new and existing guidance documents on human subject protections.

(7) Interpret human subject protection regulations and policies in a clear and consistent manner.

(8) Advise the branch chief and director of any significant/relevant changes to the requirements that relate to human subject protections.

(9) Provide advice and status updates and recommendations to the departmental branch chief such as on resolution of issues or related administrative tasks

(10) Develop briefings for the protocol team, departmental Branch Chief, and senior office and Division leadership

REQUIREMENTS. The contractor must have:

(1) Bachelors degree in Biology, Public Health, Nursing, or a related discipline. Advanced degree (Masters or Ph.D.) in relevant field preferred.

(2) Minimum of 5 years of experience in the field of human subject protection and policy development from both site and sponsor perspectives

(3) Experience with clinical research protocols and operations along with knowledge of federal regulations and guidelines


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 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. (
Posted: 2021-05-21 Expires: 2021-06-21

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Human Subjects Protection Specialist - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

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