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Clinical Protocol and Regulatory Specialist - NIH - Bethesda, MD

Kelly Services

Bethesda, MD
Job Code:
  • Biotechnology / Science
  • Healthcare
  • Research Scientists
  • Coordinators
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Job Details

Job Title Clinical Protocol and Regulatory Specialist - NIH - Bethesda, MD

Jobid US3172KS_BH1245330

Location: Bethesda, MD, 20814, USA

Description Clinical Protocol and Regulatory Specialist – NIH – Bethesda, MD

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 Clinical Protocol and Regulatory 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
- Tremendous growth opportunity
- 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:

**Protocol, Scientific and Regulatory Writing:**

+ Work with Principal Investigators (PIs) on scientific protocol writing and editing (including format and addition of administrative sections); prepare amendments and all necessary forms.
+ Work with research staff on the development of clinical research and clinical trial protocols, informed consent documents, and other regulatory or study-related documents.
+ Develop other clinical documents summarizing scientific discussions related to protocol development project.
+ Review and ensure protocols and informed consents meet regulatory requirements and are written in a compatible format with the guidelines.
+ Develop initial IND and IDE submission documents, including IND sections on the general investigational plan, chemistry, manufacturing and controls, Pharmacology/Toxicology, and previous human experience.
+ Prepare IND and IDE safety, clinical study reports, and other regulatory reports, including annual reports.
+ Collaborate and consult with team members and clinical research scientists to integrate various sources of information into a uniform language style analyzing documents for accuracy, relevance/correctness of conclusions, alternate hypotheses, editorial corrections and other issues for regulatory compliance in the production of high-quality publications and other documents.
+ Edit, rewrite or otherwise prepare publication manuscripts on clinical studies and scientific reports including special summaries from raw data for submission to regulatory agencies, or for in-house use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical and scientific communication.
**Program Support as Scientific Writer:**

+ Work with the NINDS Clinical trials Unit (CTU) and NINDS staff on the development and preparation of standard operating procedures (SOPs) pertaining to scientific and regulatory writing for the NINDS Intramural Research Program.
+ Work with staff on improving the quality of written communications.
+ Prepare draft documents for senior staff review.
+ Develop and edit newsletter announcements, web information, and other internal and external communications.
+ Attend in-person meeting located at the NIH campus in Bethesda including weekly CTU staff meetings and protocol development meetings.
+ Document NINDS and CTU meeting minutes and edit scientific review documents.
+ Initiate and oversee revisions to documents as indicated in corrective and preventive action plans.
+ Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, CTU-staff, and safety, regulatory, and monitoring entities.
+ Coordinate with other offices (e.g., Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication) to integrate and ensure consistency of new/revised documents with policies.
+ Serve as coordinator for CTU protocol development meetings and as lead contact to the protocol development team sharing information and establishing working relationships
**REQUIREMENTS.** The contractor must have:

+ Ph.D. in a related scientific discipline; three (3) years of specialized experience plus a Master’s degree is equivalent to a Ph.D.; five (5) years of specialized experience plus a Bachelor’s degree is equivalent to a Ph.D.
+ Minimum of three (3) years of experience in writing and editing scientific materials for regulatory, scientific and/or general audience.
+ Experience in a clinical research setting with protocols and clinical trials.
+ Strong 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

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