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Clinical Advisor (Site Monitor) - NIH - Rockville, MD

Company: Kelly Services
Location: Rockville
Posted on: April 10, 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 Advisor (Site Monitor)--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:--
    • Provide operational support to Contracting Officer's Representative (COR) for Division-supported contracts providing clinical trial monitoring services in the context of domestic and international settings.
    • Assist in the development of tools and processes that will enhance effectiveness and efficiency to foster a robust clinical monitoring function.
    • Develop Protocol Specific Monitoring Plans tailored to specific human subject protection and data integrity risks of the trial.
    • Shadow monitoring visits to sites as necessary to assess compliance and potential monitoring challenges in the field.
    • Assist with developing work performance reports and follow the communications management plan for access by OCSO and relevant stakeholders.
    • Assist in identification of monitoring risks and risk owner and develop risk register and management plans.
    • Review and participate in drafting new procedures and work instructions for monitoring contract services.
    • Monitor and control clinical monitoring projects, scope, schedule and communications to ensure high quality deliverables.
    • Provide advice on clinical research operations and monitoring, regulatory affairs, GCP, or other related clinical research issues such as: a) review of site trend analyses or site monitoring reports; b) identification of concerns and solutions to site performance issues; and c)identifying opportunities for improving operations through site-specific training or site-specific visits.
    • May be responsible for oversight of a small portfolio of Clinical Research Sites (CRS)(Network and Non-Network). For these sites, serve as the day-to-day contact for CRS staff to facilitate clinical research site development, protocol implementation, and other operational and regulatory issues.
    • Advise Principal Investigators on clinical site start-up issues including resource allocation, personnel management, and administrative issues. Sites may be Network affiliated sites or investigator-initiated project (Non-network) sites.
    • Direct and conduct formal evaluations of the CRS's organizational structures and modes of operation in relationship to the achievement of the Division's goals and objectives in the areas of administration, clinical site management and recruitment of participants.
    • Provide oversight and technical direction for evaluation of site performance using data compiled by Network/Non-network data management centers and other DAIDS contractors.
    • Assess the level of clinical research competency of CRSs and the extent of research knowledge and technology available to achieve the desired quality of operations at the clinical research sites.
    • Attend Network meetings, conference calls, ad hoc meetings and working groups as needed.
    • As needed, conduct trainings for sites and Network meeting participants on relevant policies and regulations.
    • Interface with NIAID program staff and with the Clinical Site and Study Monitoring (CSSM)contractor to support regular meetings related to task coordination.
    • Participate in working groups to provide technical expertise in development of new OCSO policies and standard operating procedures (SOPs).
    • Plan and prepare communications for formal delivery to relevant stakeholders at programmatic and scientific meetings--REQUIREMENTS. The contractor must have:
      • Must possess at least a B.S. degree with a minimum of 5 years of relevant experience OR M.S. degree with a minimum of 3 years of relevant experience OR PhD with a minimum of 1 year of relevant experience.
      • Experience with clinical trials site monitoring, human subject's protection, and policy development preferred.--PLEASE APPLY ONLINEWhen 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 Advisor (Site Monitor) - NIH - Rockville, MD, Other , Rockville, Maryland

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