Informed Consent Writer
ICON plc
full-time
Posted on:
Location Type: Remote
Location: United States
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About the role
- Prepare informed consent documents that disclose information about a clinical trial using health literate language
- Work across multiple therapeutic areas using MSD tools, systems, guidelines, templates, and processes
- Manage informed consent writing projects including design, planning, and preparation of documentation in support of clinical development
- Read and understand protocol-specific design, objectives, and study procedures
- Collaborate with protocol authors to ensure comprehensive understanding of protocol details.
- Resolve document issues relating to informed consent.
- Participate in clinical trial team meetings to ensure timely delivery of documents
- Support tool development, enhancements, and testing, as applicable
Requirements
- Life sciences degree
- 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience
- 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 a summary of a clinical trial design, objectives and activities for a lay audience using established guidelines
- Understanding of appropriate International Council on Harmonization (ICH) and regulatory guidance pertaining to Informed Consent
- 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
- Complete fluency in reading and writing American English
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
scientific knowledgehealth literacyprotocol structure understandingclinical trial operationsinformed consent document preparationdocument management systemsstructured content managementMS OfficeAdobe Acrobat
Soft Skills
collaborationcommunicationproject managementproblem-solving