Clinical Research Coordinator - 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 the leading medical research center in the world. We are seeking an experienced individual to work as a Clinical Research 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 NIH s unparalleled resources and niche scientific initiatives

TASKS/SERVICES. The contractor shall:

• Develop new and review completed protocol documentation including schemas, patient calendars and teaching aids
• Develop new and review completed clinical research informed consent and other ethics and regulatory related documentation
• Prepare new and review completed study reports and status updates, including amendments, audits and other administrative documentation
• Develop new and review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports.

REQUIREMENTS. The contractor must have:

• Master s degree in Clinical Research, Nursing, Biology, Life Sciences, or related discipline
• Minimum of 1 year of clinical trial experience (Phase I or II experience)
• Experience liaising with regulatory authorities
• Experience with IRB submissions
• Experience in Good Clinical Practice and regulatory compliance guidelines for clinical trials

Software

• Clinical Trial Management System (CTMS)
• Electronic Medical Records System
• Electronic Data Capture System

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 aren t 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, Kelly s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what s next.

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