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Clinical Protocol Coordinator - NIH - Bethesda, Maryland

Kelly Services

Bethesda, MD
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Job Details

Job Title Clinical Protocol Coordinator - NIH - Bethesda, Maryland

Jobid US3172RS_BH1429445

Location: Bethesda, MD, 20814, USA

Description Clinical Protocol Coordinator - NIH - Bethesda, Maryland

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 one of the most prestigious research organizations in the world. We continue to seek CLINICAL PROTOCOL COORDINATOR to work with the National Institutes of Health in Bethesda, Maryland. Bethesda is 9 miles from Washington, DC.

This is a long-term contract position which offers:
- Competitive salary with comprehensive benefit package
- Opportunity to work at NIH, world's foremost medical research center
- Learn more about what Kelly can do for you at

NNational Institute of Neurological Disorders and Stroke (NINDS)
Division of Intramural Research (DIR)
National Institutes of Health (NIH)
Bethesda, MD

TASKS/SERVICES. The contractor shall:
1. Provide support for the review processes of the Combined NeuroScience Institutional Review Board (CNS IRB); process and guide research protocols under CNS IRB auspices through the review cycle of submission, initial review, continuing review, amendments and reporting.
2. Review CNS IRB submissions to ensure the safety and protection of human research subjects and for conformance with CNS IRB, NIH, FDA, Federal and other regulations and requirements.
3. Provide educational materials and training sessions for IRB members and investigators in the member institutes.
4. Ensure that records are prepared and maintained in accordance with all applicable IRB, NIH, FDA and Federal regulations; provide guidance associated with CNS IRB functions; participate in quality assurances and quality improvement activities for the CNS IRB office and processes.
5. Serve as specialist and consultant for the Institutes in regard to protocol procedures, regulations and requirements; serve as liaison between various individuals and offices involved in the oversight of human subjects research at NIH including but not limited to, the CNS IRB, participating Institutes, the Office of Human Subjects Research Protections, the Clinical Center Office of Protocol Services and investigators.
6. Serve as liaison between the CNS IRB and those outside of NH such as private physicians, research subjects, private hospitals, the Office of Human Research Protection, the Public Health Service, the Food and Drug Administration, the Centers for Disease Control, and the Walter Reed National Naval Medical Center.
7. Provide professional expertise on issues of importance to Human Subjects Protections, such as the inclusion of special populations, including but not limited to, women of child-bearing potential, minors, prisoners, and adults without consent capacity, employees, and others in research.
8. Provide special expertise to guide the incorporation of protections for participants in research protocols.
9. Attend CNS IRB staff meetings, IRB meetings, the Human Subjects Research Advisory Committee meetings, Protocol coordinator meetings, as well as other meetings deemed necessary by the CNS IRB Chair.
10. Attend and participate in Institute scientific review committee meetings and clinical care meetings.
11. Develop guidance materials, manuals and other written and electronic resources, including the CNS IRB website and newsletters Educate investigators and staff; ensure that all CNS IRB policies and procedures are disseminated to supervisors, Clinical Directors and other Institute officials, scientific review committees, investigators and staff within the participating Institutes via written and electronic communication.
12. Provide guidelines and advice concerning regulatory compliance and quality assurance issues pertaining to clinical trials.
13. Stay current with CNS IRB, NIH, OHRP/HHS, FDA and other regulations relevant to IRB review; stay current with professional literature relevant to IRB professional staff.
14. Determine the scope when significant changes are made to protocol submission requirements; discuss the information with the Chair of the CNS IRB; relay information via memoranda, e-mail, forms and reports as needed.
15. Read, review and become familiar with content of the individual protocols, consents and actions under IRB review; recommend changes to improve subject safety and regulatory compliance.

REQUIREMENTS. The contractor must have:
1. Master's degree in a related discipline.
2. Minimum of seven (7) years of related experience.
3. Knowledge of the purpose and function of IRBs, including regulations governing IRBs including 45CFR46, 21CFR50 and 21CFR56.
4. Knowledge of NIH OHSRP IRB SOPs, NIH Clinical Center Medical Administrative Series and other policies regarding IRB review and human subject research safety at NIH.
5. Knowledge of medical terminology, clinical trial methodology and medical research procedures.
6. Knowledge of NIH, FDA and other U.S. Federal regulations, policies and procedures relating to the conduct of clinical research.
7. Familiarity with key issues of human subjects research protections, including but not lim-ited to, consent documents and process, surrogate consent, waiver of informed consent, issues regarding enrollment of vulnerable subjects and minors, multi-center trials, international trials, Federal-wide assurances, investigational drugs and devices, and the storage and future use of samples and data.
8. Strong verbal and written communications skills.
9. Excellent analytical, organizational and time management skills.

Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls or emails. All qualified candidates will be contacted.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at

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