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12 days old

Clinical Protocol Coordinator - 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 Coordinator** 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:


+ Manage Trial Master File program for all CTP studies. Develop protocol-specific TMF indexes and plans at trial start, collecti and file TMF documents throughout the trial, correspond with TMF CRO support during and after the trial, and ensure QC of final TMF at the end of the trial.

+ Advise, coordinate and plan scientific research activities for Phase I and II clinical trials for investigational vaccines and monoclonal antibodies targeting infectious diseases including influenza, HIV, malaria, etc.

+ Serve as a clinical protocol study team member, will actively engage in protocol planning and development and development and assessment of domestic and international sites.

+ Develop processes and SOPs and other documents to support TMF management.

+ Ensure adherence to processes and SOPs specific to documents under their management.

+ Ensure documents are readily available for audits and inspections.

+ Participate in internal or external audits and regulatory authority inspections as needed.

+ Provide guidance and serve as a TMF resource to colleagues. Draft, edit, and review protocols and operations manuals specific to the research projects.

+ Provide scientific and regulatory guidance and assistance to the program in support of product development.

+ Serve as a liaison to the VRC Office of Regulatory Science.

+ Review and provide input on various research agreements (interagency agreements, clinical trial agreements, etc.) to ensure the programs needs are met.


The contractor must have:


+ Masters degree; a bachelors degree with applicable job experience may be considered. Regulatory Affairs Certification (RAC) preferred.

+ Minimum 5 years of experience in the pharmaceutical/biotechnology industry, government, or equivalent, including minimum 3 years clinical document management system experience, preferably with drugs or biologics products.

+ Experience participating in internal or external audits and regulatory authority inspections preferred.

+ Demonstrates knowledge and understanding of GCP, ICH guidelines and, regulatory requirements for clinical research and TMFs.

+ Ability to work independently and as part of a team.

+ Strong organizational skills.

+ Excellent oral and written communication skills.


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: 2022-06-13 Expires: 2022-07-14

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Clinical Protocol Coordinator - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814

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