1+ months

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:

+ Provide regulatory guidance and assistance for protocol development, implementation, continuing support for NIDDK intramural research protocols.

+ Serve as the point-of-contact and project manager for an assigned portfolio of projects.

+ Work with PIs and the research team on the design, plan, production and revision of study documents, including applying clinical and regulatory knowledge to the review of protocol and informed consent documents.

+ Work with research staff to navigate requirements for protocol approval and continued conduct: complete submissions to approving bodies (e.g., scientific review, IRB and radiation safety), coordinate with PIs and the research team to ensure stipulations are addressed appropriately and on-time; track the required approvals necessary to initiate and continue intramural research.

+ Prepare program actions that do not go to the IRB such as data sharing plans, reliance agreements and technology transfer agreements.

+ Orchestrate meetings with Principal Investigators (PIs) and other key research staff to manage protocol start-up and continuation logistics.

+ Provide advice and assistance in troubleshooting human subjects protection issues.

+ Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments, and to share relevant information with Protocol Navigation (PN) and research team members.

+ Work with the Office of Human Subjects Research Protection (OHSRP) to keep abreast of new guidance related to policy governing the conduct of research at the NIH Intramural Research Program, and to share relevant information with PN and research team members.

+ Collaborate and communicate with other divisions and individuals (Regulatory Affairs, the Clinical Safety Office and site monitors) to identify the regulatory guidelines and required timelines for Food and Drug Administration (FDA) requisite activities; ensure protocol design safety issues are identified early; ensure required oversight is initiated as outlined in the protocol.

+ Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.

+ Maintain regulatory files.

+ Participate in NIDDKs Quality Assurance Program, including site initiation visits and periodic protocol monitoring.

+ Identify and make recommendations to improve the processes, procedures and policies of the Office and assist in issuing guidance.

+ Disseminate expertise and best practices related to Human Protections in clinical re-search through presentations, publications, and/or interactions with colleagues.

+ Attend meetings of various HRPP groups within NIH, including HSRAC, IPAC, etc.

REQUIREMENTS. The contractor must have:

+ Masters degree in a life science or healthcare discipline; three (3) years of specialized experience plus a Bachelors degree is equivalent to a Masters degree.

+ Minimum of four (4) years of experience managing IRB submissions.

+ Mastery of a wide range of scientific research concepts, principles, methods and techniques common to several recognized professional fields in the health, medical or allied sciences to serve as an expert and program authority to Principal Investigators and other staff responsible for approving protocols;

+ Mastery of the IRB process concepts, methods and techniques;

+ Mastery of advanced management and organizational principles and practices to plan, implement and track complex clinical research protocols encompassing a broad range of medical specialties conducted in numerous Institutes;

+ Ability to work in a clinical research regulatory setting, both independently and with a team, to coordinate, negotiate and facilitate program goals, mitigate potential problems, move projects forward expeditiously, and meet deadlines;

+ Ability to interact with a broad range of senior scientific, medical and management staff, expert advisors, and representatives of other Federal and non- Federal organizations; and

+ Expert knowledge of the NIH organization mission, structure, scientific policies and functions to design, coordinate and oversee complex special assignments of a sensitive or confidential nature.


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 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.

**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** ****

Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. Were always thinking about whats 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.


Posted: 2020-12-21 Expires: 2021-02-20

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Clinical Protocol Coordinator - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814

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