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Information Technologist – Silver Spring, MD (#14133)

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 an Information Technologist 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

Information Technologist

Essential Duties and Responsibilities

  • Lead the end-to-end delivery of data management services, primarily focused on preclinical and clinical studies.
  • Lead the delivery of data management products (clinical trial databases, data management documentation as well as data management study reports) per timelines and project specifications.
  • Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, Standard Operating Procedures (SOPs), Clinical Trials Data Management best practice guidelines, as well as Good Clinical Data Management Practices documents.
  • Serve as the main contact on Data Management (DM) activities and provide strategic DM expertise to preclinical and clinical studies.
  • Preserve strong relationships with study sites and collaborators through open, efficient and timely communications.
  • Manage and resolve issues related to Data Management deliverables by developing solutions to complex problems to ensure consistency across study sites.
  • Participate in protocol development and design, develop, and review Case Report Forms (CRF). Ensure review and quality control against associated study protocol, laboratory requirements, CRF standards templates, Good Clinical Data Management Practices, and where applicable CDISC CDASH standards.
  • Plan and lead study database setup, ensuring appropriate database documenting.
  • Perform database validation as well as User Acceptance Testing (UAT), and document databases in accordance with programming standards and validation procedures.
  • Responsible to set up and review Data Management documentation, clearly outlining the project data management processes.
  • Responsible to monitor data management operational activities through quality control procedures, identifying individual and systemic data anomalies, as well as institution of corrective and preventative action plans (e.g. additional edit checks, data monitoring reports and/or listings, email alerting, etc.).
  • Understand and comply with GCP, SOPs, regulatory requirements, and Good Clinical Data Management Practices.
  • Work with and train local site data managers to understand and comply with GCP, SOPs, regulatory requirements, and Good Clinical Data Management Practices.
  • Meet objectives as assigned and interact with study teams to organize timelines, responsibilities and data management deliverables.
  • Build and maintain strong communication and working relationships with internal and external team members (timely email communication, telephone meeting as well as face to face meeting attendance).
  • Develop, implement, test, and monitor quality control of new technologies with guidance from Clinical Trials Data Management team as well as more experienced team members.
  • Develop data management training tools and train sites in data collection, data quality, and database use.
  • Review and develop Data Management SOPs and Clinical Trials Data Management best practice guidelines.
  • Extract and merge data sets from databases into the desired format for evaluation by other team members for QC or report purposes.
  • Other activities determined as important by management team.
  • International travel for 1-2 weeks at a time 2-4 times each year.

 

Supervisory/Management Authority

  • This position will not have supervisory authority.

 

Education and/or Experience

  • IT specialist with at least 3 years of similar job experience. 
  • Capable of programming databases, CRF creation – both electronic and hardcopy, and information transfer.

 

Knowledge, Skills and Abilities

  • Competent in networks, Microsoft Office, Microsoft Access, Microsoft SQL Server; familiarity with Oracle and Study Manager
  • 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.