Safety Associate I

This job requires a person to be highly customer focused with excellent computer skills, including proficiency with MS Office. This position requires organizational skills with a high attention for detail. The ability to work in a team environment, meet deadlines, and prioritize. Excellent verbal and written communication skills are essential. Successful team member will support the Safety Services team, Clinical Operations project teams, and the Data Management team for the management of ongoing clinical studies and Pharmacovigilance-only projects.

Responsibilities

  • Departmental Infrastructure
    • Collaborates with Head of Safety Services to establish work priorities
    • Maintains tracking tools for departmental key performance/quality indicator metrics
    • Meets key performance indicators and quality targets established by Head of Safety Services
    • Attends study team meetings and company staff meetings
    • Assists Safety Services in the preparation of Safety reports (aggregate safety reports, Safety database listings)
    • Performs any additional related work as required and assigned by Head of Safety Services
    • Assists Safety Services in quality assurance activities including audits
    • Develop knowledge of: Global clinical trial Good Vigilance Practices for medical devices, pharmaceuticals, biologics, and combination products; Safety Services best writing practices and data entry conventions
    • Liaises with translation service providers on behalf of Safety Services
  • Individual Safety Case Reports (ICSRs)
    • Set up and maintenance of project-related electronic and/or paper files for clinical study Trial Master File inclusion
    • Reviews and tracks incoming ICSRs for completeness; submits site query requests to Data Management
    • Performs initial data entry of ICSRs into tracking system / Safety database
    • Organizes personal workload to ensure compliance with project-specific timelines and global reporting requirements for ICSRs
    • Performs quality check of peer ICSRs to ensure adherence to SOPs and study requirements (if applicable)
    • Assists in the submission of expedited ICSRs to regulatory agencies
    • Distributes Sponsor cross reports to investigator staff
    • Maintains solid knowledge of assigned study protocols for study-specific adverse event definitions, handling, and reporting requirements
  • Clinical Events Committee (CEC)
    • Supports CEC Coordinator by gathering CEC member documents, tracking events for adjudication, preparing adjudication document packages, writing narratives if required, quality checking package documents for completeness and accuracy, and generating meeting agendas and highlights
    • Participates in Electronic CRF CEC module set up and user acceptance testing.
    • Utilizes CEC module to prepare events for adjudication by CEC members.
    • Tracks adjudication completion by CEC members/chair within CEC module.
    • Maintains Trial Master File documentation for CEC activities.
  • Data Monitoring Committee (DMC)
    • Supports DMC Coordinator by gathering DMC member documents and generating meeting highlights as required
    • Maintains Trial Master File documentation for DMC activities.

Qualifications

  • Bachelor's degree from a four-year college or university in Life Sciences or related field; or RN diploma
  • Understanding of medical terminology and industry acronyms preferred
  • Competence with Microsoft Word and Microsoft Excel
  • Ability to perform basic searches via the internet or other comparable data repositories
  • Demonstrates attention to detail and organizational skills, develops time management skills, pro-active and displays a professional demeanor with focus on compliance and responsibilities
  • Good verbal and written communication skills
  • Excellent interpersonal skills
  • Ability to work collaboratively and effectively in a team environment
  • High attention to detail and level of accuracy
  • High degree of tact, judgment and discretion
City
Lower Gwynedd
State
PA
Job Type
Full-Time Regular
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