1+ months

Human Research Protection 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 one of the most prestigious research organizations in the world. We are currently seeking a Human Research Protection Specialist to work onsite with the National Institutes of Health in Bethesda, MD **.**

This is a long-term contract position which offers:

- Competitive salary with comprehensive benefit package

- Opportunity to work at NIH, the world's foremost medical research center

- Learn more about what Kelly can do for you at at

**TASKS.** The contractor shall:

+ Serve as Human Research Protection Specialist in the NIMH Human Research Protection Branch.

+ Serve as advisor to the NIMH Office of Clinical Research (OCR) staff and colleagues.

+ Serve as a resource for ethical and regulatory inquiries in the field of mental health research.

+ Evaluate human research protection plans and data and safety monitoring plans.

+ Serve as Scientific Administrator for the NIMH Data and Safety Monitoring Boards (DSMBs).

+ Provide advice to staff in designing data and safety monitoring plans for NIMH-funded clinical trials.

+ Identify inadequacies and inconsistencies in scientific and regulatory data.

+ Develop and deliver training/education to key stakeholders; develop extramural human research protection policies and standard operating procedures.

+ Provide advice to NIMH Director of Clinical Research (DCR) and NIMH Program Officials on National Advisory Mental Health Council applications and policy matters related to human subject protection.

+ Independently research background information regarding clinical research ethics and federal human subject protection regulations.

+ Interpret findings of the analyses; prepare reports and informational materials for presentation to management, other governmental and non-governmental agencies, scientific meetings, Data and Safety Monitoring Board meetings, etc.

+ Identify, document and resolve critical human subject protection issues.

+ Prepare meeting agendas and meeting summaries; coordinate meeting plans.

+ Interpret findings of analyses; prepare reports and information materials for presentation,

+ Interpret regulations and guidance from various federal agencies as related to research projects and programs.

+ Provide guidance to DCR and NIMH Program Officials regarding a variety of complex and sensitive mental health issues covering the full range of NIMH program areas, especially clinical research and issues such as research ethics, informed consent, vulnerable research participant populations, review and evaluation of unanticipated events, and other human research protection issues.

**REQUIREMENTS.** The contractor must have:

+ Ph.D. in a Science or Health related discipline; three (3) years of specialized experience plus a Masters degree is equivalent to a Ph.D.

+ Minimum of three (3) years of experience working in a human research protection program such as an Institutional Review Board office or as a clinical research policy advisor.

+ Expert knowledge of Microsoft Office Suite (MS Word, Excel, Outlook, PowerPoint, SharePoint) and database searches.

+ Excellent communications skills, both oral and written.

+ 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. 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
Posted: 2019-10-18 Expires: 2019-12-19

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Human Research Protection Specialist - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814

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