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26 days old

Clinical Protocol Monitoring Specialist - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814
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 **Clinical Protocol Monitor Specialist** at the National Institutes of Health in Bethesda, 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:


**Provides assistance in the regulatory oversight, fiscal and operations management of new clinical trial protocols preparation.**


+ Assist in the preparation of new clinical trial protocols.


+ Serve as a Clinical Trials Specialist, with responsibility for carrying out administrative and information management functions for clinical trials and related research being conducted within the section.


**Coordinates submissions of all new clinical trial protocols to multiple regulatory agencies.**


+ Work with staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing.


+ Collaborate with staff on initial submissions, continuing reviews, amendments, audits and other administrative requirements.


**Develops database to track all clinical trial documents, report submissions, review submissions, etc.**


+ Distribute and track all new clinical trial protocol documents to the protocol development team to ensure proper document control, through the initial draft until the final version prior to the start of a study.


+ Use and revise/create data capture forms to meet study needs.


+ Track, organize and generate analyses and reports using available databases for evaluation of project needs.


**Monitor clinical trial progress.**


+ Conduct site visits to monitor clinical trial progress.


+ Validate required documentation is being maintained.


+ Review site visit findings with investigator.


REQUIREMENTS. The contractor must have:


+ Masters in a science field


Certifications & Licenses


+ Clinical Research Associate (CRA)


Skills (Ranked By Priority)


1. SOPs

2. Site monitoring

3. Data Monitoring

4. Regulatory compliance

5. Data Integrity

6. Regulatory affairs


**1, 2, 3, 4, 5** _represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked_


Software


+ Electronic Medical Records System

+ Electronic Data Capture System


Field of Study


+ Health and Medical Administrative Services


Please Note: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.


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.


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.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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)

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Posted: 2022-05-02 Expires: 2022-06-02

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Clinical Protocol Monitoring Specialist - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814

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