Peraton Corporation

  • Clinical Data Specialist

    Job Locations US-MD-Bethesda
    Posted Date 1 week ago(6/12/2018 9:27 AM)
    Requisition ID
    2018-6125
    Category
    Other
    Clearance Status
    None
    Security Clearance
    None
  • Overview

    We are seeking a  Clinical Data Specialist III in Bethesda, MD to support our National Heart, Lung and Blood Institute customer.

     

     

     

    Responsibilities

    • Manage the delivery of high quality data from project start-up and planning to project execution and project closeout on several projects.
    • Analyze content of source documents (e.g. medical records, Hospital information systems) and perform data abstraction and data entry on several different protocols into multiple clinical databases.
    • Analyze and record appropriate adverse events (AE’s) based on protocol requirements and individual judgment in applying those requirements.
    • Manage submissions to sponsors and regulatory agencies based on knowledge and understanding of study requirements.
    • Validate and reconcile data from multi-institutional study sites as required.
      • Independently perform project specific quality control and quality assurance tasks on all projects responsible for as well as when requested by Peraton management.
      • Contribute to the design of the databases and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity.
      • Interpret, analyze and extrapolate data to create reports, graphs, and schemas for Principal Investigator (PI) analysis based on judgment, knowledge and understanding of study requirements.
      • Take a leadership role in coordination and oversight of the projects of increased complexity: CIBMTR, Multi-site studies.
      • Communicate projects’ status and key project issues to management. Perform other duties as directed by CDM Manager, and research team.
      • Demonstrate a significant amount of initiative, autonomy and proficiency in all of the above areas. Collaborate with management and research team in resolving issues and concerns identified.
      • Actively participate in the Preceptor Training Program and in training and orientation activities within their assigned team as well as for staff outside their team.
      • Develop and maintain good communications and working relationships within Peraton CDM staff and government research team.

    Qualifications

    REQUIRED EXPERIENCE:

    • RN, MS or BS/BA in health-related field
    • Minimum of 3 years of medical, clinical, or research related study or instruction. 5 plus years’ experience can be substituted for education
    • Certifications preferred: CCRP certification
    • Clearance required: none

    PREFERRED QUALIFICATIONS:

    • MS in health-related field, and 3+ years experience
    • Experience in cardio-vascular, pulmonary, hematology clinical  research preferred
    • Clinical and/or data management certification (e.g., CCRP) highly desirable
    • Strong communication skills
    • Excellent teamwork

    Please be aware that many of our positions require a security clearance, or the ability to obtain one.  Security clearances may only be granted to U.S. citizens.  In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information. 

    About Peraton

    Peraton provides innovative, reliable solutions to the nation’s most sensitive and mission-critical programs and systems. Peraton has significant experience providing highly differentiated secure communications, space, and technology solutions to key customers, and has become a trusted partner on missions that are critical to the security priorities of the United States. Capabilities include complex software and technology services and solutions, as well as end-to-end mission operations abilities, including Software Systems Development, Cyber, Modeling & Simulation, Mission Operations, Signal Intelligence (SIGINT), and Quick Reaction Capabilities (QRC) / Research & Development. The company is headquartered in Herndon, VA, with approximately 3,500 employees across the U.S. and Canada. 

    EEO Statement

    We are an Equal Opportunity/Affirmative Action Employer. We consider applicants without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, or membership in any other group protected by federal, state, or local law.

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