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 to work as a **Clinical Trials Advisor (ACTIV
2 Study)** at the National Institutes of Health in Rockville,
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 NIH's unparalleled resources and niche scientific
**TASKS/SERVICES. The contractor shall:**
+ Create an overall operational plan for the ACTIV 2 study,
including timeline, key milestones, resources needed and budget.
The ACTIV 2 study is the U.S. Government's premier effort to
develop data on promising therapies for outpatients suffering from
COVID19 disease. The study is a complex platform study, capable of
testing multiple investigational products simultaneously. It is an
adaptive design spanning traditional phase 2 and phase 3 of
clinical development. It is being conducted under the auspices of
the NIH, Operation Warp Speed (OWS) and the NIH-funded AIDS
Clinical Trial Group (ACTG).
+ Assess the operational feasibility and resource considerations
of new entrants to the trial.
+ Working through established contract resource organizations
and with the sponsor and networks:
+ Create a global site/country strategy Oversee the execution of
that strategy including site selection including feasibility,
qualification and pre-study assessment
+ Oversee site activation including, the provision of
investigational product, non-IP clinical supplies and laboratory
materials; the completion of required regulatory documentation and
the granting of needed systems access.
+ Coordinate efforts to recruit participants into the trial
including global trial and site specific recruitment plans, media
and outreach programs and vendor programs.
+ Oversee the execution of the study monitoring and oversight
plan. Ensure site productivity and quality issues are actively
+ Oversee the executions of the data management plan. Ensure
that queries are resolved and database closure occurs on time.
+ Oversee the study close-out plan.
+ Create and oversee the execution of a study risk management
plan. Proactively resolve risks to operational delivery.
+ Lead team meetings. Support meeting documentation and
follow-up action items.
+ Facilitate reporting of study status to key stakeholders in
NIH, OWS and ACTG.
**REQUIREMENTS. The contractor must have:**
+ Master's degree or PhD in a related discipline; or
Professional Degree (i.e. RN or MD)
+ Experience working with all phases of clinical trials.
+ At least ten (10) years of clinical trials experience is
+ Industry (contract research organization or sponsor) work
+ Experience in infectious diseases research and/or
**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
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.
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
**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. It's just another way we make the job search work for
**About Kelly** ****
Kelly connects talented people to companies in need of their
skills in areas including Science, Engineering, Education, Office,
Contact Center, Light Industrial, and more. We're always thinking
about what's next in the evolving world of work, and we help people
ditch the script on old ways of thinking and embrace the value of
all workstyles in the workplace. We directly employ nearly 500,000
people around the world, and we connect thousands more with work
through our global network of talent suppliers and partners in our
outsourcing and consulting practice.
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