JobWatch

27 days old

Human Subjects Research Protection Specialist (Clinical Research) - 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 Research Protection Specialist (Clinical Research Advisor) 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. Develop, draft, and compile policy or procedures documents either independently or as part of a working group in support of the overall functions of the Protections of Participants, Evaluation and Policy Branch (ProPEP) in the Division of AIDS (DAIDS)

2. Provide leadership, editorial expertise, and consultative support to the Division of AIDS through creation of clinical research policies and related procedures, as well as DAIDS human subjects clinical research policies, in compliance with all applicable US federal regulations and international guidelines, such as ICH, and other relevant guidelines.

3. Provide DAIDS staff advice on the interpretation of human subjects protections regulations, protocol compliance in the area of human subject protections, and the additional requirements under 45 CFR 46 Subparts B, C, and D as well as other applicable regulations (21 CFR 50, etc.) and guidelines (ICH and others as applicable).

4. Serve as the subject matter expert, providing expertise on HIV, associated comorbidities (such as TB), etc. needed to evaluate human subject protection issues, and maintain such scientific expertise.

5. Contribute to the review of individual protocols presented at DAIDS Scientific Review Committees, from a human subject protection perspective.

6. Provide direct human subjects protections support to protocol development teams, clinical operations offices, project specific working groups and other DAIDS and DAIDS Stakeholders in their oversight of the implementation of DAIDS sponsored and/or funded clinical research.

7. (7) Provide advice and develop policy briefings to inform the departmental Branch Chief and leadership of activities related to policies; perform project management, and administrative tasks related to development and/or modification of policies and procedures.

8. Conduct in-depth research for development and/or modification of clinical research policies in a variety of areas (for example, clinical trial conduct and oversight, safety, research participant privacy protections).

9. Provide NIH and NIAID-wide benchmarking, policy research, and analyses in support of DAIDS policy development, management, and/or administration.

10. Serve as a content manager for the internal (ProPEP) policies and procedures and DAIDS external clinical research policy website.


REQUIREMENTS. The contractor must have at least:


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 relevant experience in the field of human subject protection and policy development.

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


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 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)
Posted: 2021-04-12 Expires: 2021-05-13

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Human Subjects Research Protection Specialist (Clinical Research) - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast