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Clinical Research Coordinator (Auditing/Monitoring) - NIH - Bethesda, MD

Kelly Services

Bethesda, MD 20814
Kelly Services
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Clinical Research Coordinator (Auditing/Monitoring) 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 Research Coordinator (Auditing/Monitoring) 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:

+ Perform Site Initiation Visits (SIV) for all new IRB approved protocols, as requested by the Principle Investigator.

+ Perform random and for-cause audits of protocols in the NINDS intramural research program in accord with FDA regulations, ICH GCP and NIH policy.

+ Perform monitoring (SIV, interim, and COV) of FDA regulated clinical and natural history trials in accord with FDA regulations, ICH GCP, and NIH policy, per the NINDS QA SOP.

+ Generate reports on quality assurance findings regarding compliance and trends.

+ Provide support to research team members from study start through study closure.

+ Develop or assist in the development of Corrective and Preventative Action Plans.

+ Provide operational support through education, training and quality improvement initiatives and development and maintenance of SOPs.

+ Design new QAreport templates and sample Case Report Forms (CRF) templates associated with the Standard Operating Procedures (SOPs).

+ Maintain the FileMaker database for the NINDS Clinical Trials Unit, QA Office.

+ Contribute to protocol development through active participation in Protocol Development Meetings with investigators and CTU members.

**REQUIREMENTS.** The contractor must have:

+ Masters degree in Biology, Chemistry or a related discipline; three (3) years of specialized experience plus a Bachelors degree is equivalent to a Masters degree.

+ Minimum of two (2) years of related experience.

+ Knowledge of FDA regulatory requirements.

+ 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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