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Manager, Clinical Compliance Process

Lake Forest, Illinois 60045

Post Date: 03/15/2018 Job ID: 1881 Job Category: Clinical: Quality

Job Responsibilities:
  • Support inspection readiness activities and execute quality control of various documents and files
  • Review and message management of clinical trials email-box, and other central e-mail as assigned
  • Review of the public disclosure tracker for upcoming due dates for registration/results
  • Assisting with generation of disclosure packets for contract public disclosure writers
  • Review regulatory agency websites for pertinent updates
  • Assisting with vendor KPI completion and tracking
  • Assisting with policy, SOP, forms, templates, and plans generation and editing/formatting as assigned
  • Supporting Open Payments and other requirements for financial transparency by gathering and compiling data as assigned
  • Support as needed and assigned other Clinical Compliance projects, initiatives, and requirements

Qualifications/ Requirements:
  • Bachelor’ s Degree, preferably in healthcare or clinical research
  • Strong technical writing skills
  • Ability to work under pressure and maintain flexibility
  • Attention to detail
  • Solid knowledge of applicable regulations and guidance. Knowledge of multiple public disclosure registries (, EU CTR, ENCePP, etc.).
  • Proficient with all MS Office applications, SharePoint, Adobe Acrobat
  • Excellent communication skills / flawless spoken and written English, additional language(s) a plus
  • Never disqualified or sanctioned by a regulatory agency
  • Able to provide at least two references and a writing sample
  • Able to travel occasionally if requested
  • Able to lift/ move a full file box on occasion if needed
  • Essential Core Competencies:
    • Action Oriented
    • Problem Solving
    • Organization
    • Functional/Technical Skills
    • Priority Setting
    • Drive for Results
    • Strategic Agility
    • Intellectual Horsepower
    • Dealing with Ambiguity
  • Core Behaviors:
    • Integrity and Trust
    • Composure
    • Standing Alone

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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