[Hiring] Informed Consent Writer @ICON plc

Role Description

The Informed Consent Writer (ICW) is responsible for preparing informed consent documents that disclose information about a clinical trial using health literate language to help a candidate make an informed decision about trial participation. The ICW will work across multiple therapeutic areas using client tools, systems, guidelines, templates, and processes.

• Scientific Knowledge/Health Literacy
  • Understanding of protocol structure and knowledge of the relevant information needed to create an informed consent document
  • Understanding of clinical trial operations with specific knowledge of informed consent forms
  • Ability to prepare, with minimal supervision, a summary of a clinical trial design, objectives and activities for a lay audience using established guidelines and governmental regulations in a clear, concise and health-literate format
  • Understanding of appropriate International Council on Harmonization (ICH) and regulatory guidance pertaining to Informed Consent
• Technology Skills
  • Technical expertise in MS Office (Word, Excel, Project) and Adobe Acrobat
  • Experience working in document management systems; managing workflows
  • Experience with collaborative authoring and review tool
  • Understanding of structured content management concepts
  • Flexibility in adapting to new tools and technology
• Other
  • Ability to work in a deadline-driven environment, and ability to work both independently and collaboratively with teams
  • Complete fluency in reading and writing American English
  • Excellent communication skills (email responses, meeting presentations)
  • Effective time management, organizational, and interpersonal skills
  • Customer focus
  • Strong project management skills

Qualifications

• Life sciences degree
• 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience

Responsibilities

• Read and understand protocol-specific design, objectives, and study procedures
• Prepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (when appropriate), and required risk language
• Work with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timeline
• Write, edit and review informed consent documents that reflect the principles of health literacy
• Manage informed consent writing projects including the design, planning, and preparation of documentation in support of clinical development
• Participate, when appropriate, in clinical trial team meetings to ensure timely delivery of the informed consent document(s)
• Resolve document issues relating to informed consent
• Support Global Clinical Trial Operations with informed consent process expertise and study specific support
• Possible participation in the orientation and coaching of junior team members
• Possible participation in initiatives to improve medical writing processes and standards
• Support tool development, enhancements, and testing, as applicable
• Ensure compliance with company training and time reporting

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others