Informed Consent Writer

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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 tools, systems, guidelines, templates, and processes. The ICW is to demonstrate the following skills:

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

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 Harmonisation (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

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

Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.