Informed Consent Writer
ICON Strategic Solutions · United States
- Hybrid
- Full-time
- $75,000 / year
- United States
Job highlights
- Write health-literate informed consent documents.
- Work with clinical trial protocols and teams.
- Utilize MS Office and document management systems.
- Manage project timelines and documentation.
- Contribute to improving medical writing processes.
About the role
About ICON
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Job Summary
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.Key Responsibilities
- Prepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries, 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 in clinical trial team meetings to ensure timely delivery of informed consent documents.
- 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.
- Ensure compliance with company training and time reporting.
Skills and Qualifications
Scientific Knowledge/Health Literacy
- Understanding of protocol structure and knowledge of relevant information for informed consent documents.
- Understanding of clinical trial operations with specific knowledge of informed consent forms.
- Ability to prepare a summary of clinical trial design, objectives, and activities for a lay audience using established guidelines and governmental regulations in a clear, concise, and health-literate format with minimal supervision.
- 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 tools.
- Understanding of structured content management concepts.
- Flexibility in adapting to new tools and technology.
Other Skills
- Ability to work in a deadline-driven environment, independently and collaboratively.
- 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.
Education & Experience
- Life sciences degree.
- 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience.
What ICON Can Offer You
ICON offers a competitive salary and a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance. Benefits may include various annual leave entitlements, health insurance, competitive retirement planning, a Global Employee Assistance Programme (LifeWorks), life assurance, and flexible country-specific optional benefits.Inclusion and Belonging
ICON is committed to fostering an inclusive and belonging culture, providing an inclusive and accessible environment for all candidates. ICON 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. ICON provides reasonable accommodations for medical conditions or disabilities during the application process.Key skills/competency
Informed Consent Writer, Health Literacy, Clinical Trials, Protocol Authoring, Medical Writing, ICH Guidelines, MS Office, Adobe Acrobat, Document Management Systems, Project Management.Skills & topics
- Informed Consent Writer
- Medical Writer
- Clinical Research
- Health Literacy
- Protocol
- ICH Guidelines
- Life Sciences
- Regulatory Writing
- Remote Job
- ICON plc
How to get hired
- Tailor your resume: Highlight your life sciences degree and 3-5 years experience, focusing on translating scientific material for a lay audience.
- Showcase relevant skills: Emphasize your scientific knowledge, health literacy, and technical proficiency in MS Office and Adobe Acrobat.
- Demonstrate project management: Detail your experience managing documentation projects and working in deadline-driven environments.
- Express communication strengths: Prepare to discuss your excellent written and verbal communication skills, especially in American English.
- Understand ICON's culture: Research ICON's commitment to innovation, diversity, and patient well-being to align your application and interview responses.
Technical preparation
Master MS Office suite (Word, Excel, Project).,Gain experience with document management systems.,Familiarize yourself with collaborative authoring tools.,Understand structured content management concepts.
Behavioral questions
How do you ensure clarity in complex scientific writing?,Describe a time you managed competing deadlines.,How do you collaborate with diverse teams?,How do you approach learning new technologies?
Frequently asked questions
- What is the primary responsibility of an Informed Consent Writer at ICON Strategic Solutions?
- The primary responsibility of an Informed Consent Writer at ICON Strategic Solutions is to prepare clear, health-literate informed consent documents for clinical trials, ensuring participants can make informed decisions about their trial participation.
- What educational background is typically required for an Informed Consent Writer role at ICON?
- A life sciences degree is typically required for an Informed Consent Writer role at ICON. Relevant experience, particularly in translating scientific material for a lay audience, is also highly valued.
- What technical skills are essential for an Informed Consent Writer at ICON Strategic Solutions?
- Essential technical skills for an Informed Consent Writer include proficiency in MS Office (Word, Excel, Project), Adobe Acrobat, experience with document management systems, and familiarity with collaborative authoring and review tools.
- Is the Informed Consent Writer position at ICON remote?
- Yes, the Informed Consent Writer position at ICON Strategic Solutions is a remote role, allowing flexibility in work location.
- What is ICON's stance on diversity and inclusion for job applicants?
- ICON is committed to fostering an inclusive and diverse culture and provides equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. They also offer reasonable accommodations for individuals with disabilities during the application process.
- How does ICON support employee well-being?
- ICON supports employee well-being through a competitive benefits package that may include health insurance, retirement planning, a Global Employee Assistance Programme (LifeWorks), and various other country-specific benefits focused on work-life balance.
- What does 'health literate language' mean in the context of an Informed Consent Writer at ICON?
- Health literate language, for an Informed Consent Writer at ICON, means using clear, concise, and easily understandable terms to explain complex clinical trial information, ensuring potential participants can fully grasp the details and make an informed decision.
- What kind of experience is preferred for the Informed Consent Writer role?
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