Informed Consent Writer

About the role

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. The ICW is to demonstrate the following skills:

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)
• Solids skills in time management, organization, and interpersonal skills
• Customer focus
• Strong project management skills

Education

• Lifesciences 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

What ICON can offer you:

• Variety of 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others