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Clinical Trials Advisor (ACTIV 2 Study) - NIH - Rockville, MD

Company: Kelly Services
Location: Rockville
Posted on: June 6, 2021

Job 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 to work as a **Clinical Trials Advisor (ACTIV 2 Study)** 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 NIH's unparalleled resources and niche scientific initiatives

**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 managed.

+ 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 required.

+ Industry (contract research organization or sponsor) work experience preferred.

+ Experience in infectious diseases research and/or immunology.


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.

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. It's just another way we make the job search work for you.

**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 Law. (

Keywords: Kelly Services, Rockville , Clinical Trials Advisor (ACTIV 2 Study) - NIH - Rockville, MD, Other , Rockville, Maryland

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