• Clinlogix, LLC
  • $89,780.00 -149,200.00/year*
  • Elizabethtown , PA
  • Energy/Power
  • Full-Time
  • 48 Old Hershey Rd

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.

  • 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 (periodic safety reports, Argus line listings)
  • Performs any additional related work as required and assigned by Head of Safety Services
  • Assists Safety Services in quality assurance activities including audits, development of templates and guidelines
  • Develops and maintains 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
  • 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 and clarity; submits site query requests to Data Management and/or investigative sites. Reviews investigational product literature for event expectedness/listedness for triage determination
  • Distributes notification of ICSR to Sponsor and Clinical Operations team, including case triage and regulatory submission requirements/deadline
  • Performs complete data entry of ICSRs into tracking system, regulatory report, and/or Argus safety database. Writes ICSR narratives
  • 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)
  • Submits ICSRs to regulatory agencies
  • Distributes Sponsor partner cross reports and expedited safety 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)
  • Acts as a CEC Coordinator. Co-authors CEC charter with Head of Safety or Co-CEC Coordinator. Gathers CEC member documents, tracks events for adjudication, prepares adjudication document packages, generates meeting agendas and highlights. Participates in project-specific meetings as required. Participates in CEC adjudication database set-up.
  • Data Monitoring Committee (DMC)
  • Supports DMC Coordinator by gathering DMC member documents and generating meeting highlights as required
  • Bachelor s degree from a four-year college or university in Life Sciences or related field; or RN diploma
  • At least 1-year experience in ICSR processing required
  • Clinical Events Committee adjudication coordination experience a plus
  • Understanding of medical terminology and industry acronyms
  • 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

  • Associated topics: clinical, environment, health, nursing, safety, sewer system, treatment, usda, wastewater treatment plant, water

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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