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Head Internal Quality AssuranceSilver Spring, MD (#14116)

Cherokee Nation Assurance (CNA) delivers a broad spectrum of professional management consulting services to its defense, health, environmental and civilian agency clients. To assist clients in achieving their goals, CNA provides a tailored management approach for complex government programs and disciplines including health information technology, research & science, program management, communications, correspondence and document management, governance and administrative support. Wholly owned by Cherokee Nation, CNA is part of the Cherokee Nation Businesses family of companies.

For more company information, visit our site at http://cherokee-cna.com/Pages/Home.aspx

We are seeking a Head, Internal Quality Assurance to support federally regulated research requirements to develop new medical products for the Warfighter including but not limited to support necessary to conduct clinical trials, analyze resulting data, and generate study reports.

The mission of our client, the Walter Reed Walter Reed Army Institute of Research (WRAIR), is to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements, and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the war fighter

Head Internal Quality Assurance

Essential Duties and Responsibilities

  • Plan and lead GCP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.
  • Assess GCP compliance risk areas and develop and implement risk mitigation measures; ensure compliance with company’s procedures and regulatory requirements.
  • Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
  • Review and provide input in to non-clinical documentation (e.g. protocols, study reports).
  • Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
  • Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers.
  • Provide guidance, interpretation and information on GCP regulations, standards and quality systems; develop and implement standards, policies and procedures for GCP regulatory compliance.
  • Develop and measure quality metrics to drive consistent quality standards relating to GCP activities.
  • Performs other job related duties as assigned.

Supervisory/Management Authority

  • This position will have supervisory authority.

Education and/or Experience

  • Requires Five years of experience as a Clinical Research Administrator. 

Knowledge, Skills and Abilities

  • Clinical Research Administrator or Registered Nurse.
  • Must be able to obtain and maintain a favorable National Agency Check (NAC).
  • Must be a US citizen.

 

Work Environment

Work is conducted in a laboratory, office or clinical/hospital environment; possible evening and/or weekend hours. Requires work on military base with requirement for background investigation.

With $400 million in annual revenue, 20% growth per year, approximately 950+ active contracts serving 60+ government agencies in 25 countries, 47 states, 2 territories and 2000+ employees, Cherokee Nation Businesses’ (CNB) group of Federal Contracting Section 8(a) companies is well positioned to deliver expertise needed to solve complex technical issues. Federal Solutions provides an array of services for 12 of the 15 cabinet-level departments and agencies – from applications and data services to cybersecurity and national defense.

Why consider Cherokee Nation and our Federal Solutions business? Here are some great resources highlighting what we do and compelling reasons for joining our team!

http://cherokeenationbusinesses.com/Pages/home.aspx

http://cherokeenationbusinesses.com/careers/Pages/home.aspx

http://cherokeenationbusinesses.com/federalSolutions/Pages/overview.aspx

Applicants selected will be subject to a U.S. Government security investigation and must meet eligibility requirements for access to classified information.

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, gender identity and sexual orientation. If you’d like more information about your EEO rights as an applicant under the law, please copy and paste the links to the following two sites: EEO Statement | EEO Poster

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may email “CNB.Compliance@cn-bus.com” for assistance. This email address is for accommodation requests only and cannot be used to inquire about the application process or status.

For Pay Transparency Non Discrimination provision, please copy and paste the following link: Pay Transparency Nondiscrimination Provision

We maintain an Affirmative Action Plan for the purpose of proactively seeking employment and advancement for qualified protected veterans and individuals with disabilities. Upon request, we will schedule time to make our Affirmative Action Plan accessible. If you are interested, please submit a written request with the email subject line: 2018 Request to View Affirmative Action Plan to the Compliance Administrator at “CNB.Compliance@cn-bus.com” This email box is not for resumes or follow up on job applications.