Sr. Clinical Trial Protocol Coordinator - NIH

Job Description

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 a Senior Clinical Trial Protocol Coordinator to support the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) in Bethesda, MD.  The role involves full-time, on-site work (5 days/week) on the main NIH campus in Bethesda, MD. 

This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans
- Paid leave, paid federal holidays, and 401K plan.  
- Access to NIH’s unparalleled resources and niche scientific initiatives

 
KEY TASKS 
(1) Assist Principal Investigators in the planning, development, and implementation of clinical protocols for evaluation of Vaccine Research Center investigational vaccine and monoclonal antibody products. 
(2) Ensure that clinical research protocols, consent forms, Investigator Brochures and other clinical research documents are in compliance with applicable regulatory requirements defined by the Code of Federal Regulations (CFR) and Good Clinical Practice guidelines. 
(3) Ensure that data collection plans are consistent with applicable regulatory requirements and the protocol objectives. 
(4) Assist in protocol training, study implementation, site management and reporting of study outcomes. 
(5) Design, write and develop documents related to the use of investigational products, including but not limited to: conducting background research, reviewing and interpreting scientific and technical information, technical writing, ensuring compliance with regulatory requirements, and preparing or editing scientific summaries, presentations and publications. 
(6) Prepare and review regulatory submissions, annual reports, IND safety reports, human subjects experience sections for investigator brochures and other supporting documents for vaccine and other related product types. 
(7) Manage protocol and trial development by working and coordinating with clinical research teams that include physicians, laboratory scientists, research nurses, pharmacists, regulatory personnel, and support staff. 
(8) Manage clinical trial activities and communications with study team member throughout the protocol life cycle. 
(9) Use systems for data management and document control, support the dissemination of information on vaccine, monoclonal antibody and other clinical trials and coordinate response to related inquiries from sites, sponsors, FDA, and other regulatory agencies. 
(10) Assist with quality management activities for the Program by reviewing and developing policies and procedures and provide support to risk assessment and clinical monitoring activities. 
(11) Design and conduct assessments of quality management and regulatory performance with respect to the achievement of program goals and objectives. 

KEY REQUIREMENTS
(1) Master’s degree in Life Sciences or related discipline. Two years of specialized experience plus a bachelor’s degree is equivalent.
(2) Minimum of two (2) years of clinical research experience.  Expertise in the fundamentals of clinical trials including protocol development, clinical research policies and procedures, clinical data management, and database operations and analysis. Familiarity with IRB requirements and related regulatory requirements. 
(3) Ability to review, collect, assess and summarize scientific and other complex data and information related to the development of investigational products. 
(4) Knowledge of tools and software such as MS Word, clinical data management systems, medical publication databases, document control systems, and other information systems that support clinical research. 

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 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 part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, short-term disability, and a transportation spending account.
Visit -mykelly/perks/ for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Government Solutions?

Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the world’s most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to 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

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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