Informed Consent Writer

Informed Consent Writer

1. Burlington, Blue Bell

ID: JR142387

1. Medical Writing
2.  
3. ICON Strategic Solutions
4.  
5. Remote

Job Description:

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.

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)
• Effective time management, organizational, and interpersonal skills
• Customer focus
• Strong project management skills

 

Education

• 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

 

The Informed Consent Writer (ICW) is responsible for writing informed consent documents that present clinical trial information in accessible and understandable language to help applicants make an informed decision about participating in the trial.
The ICW will work across multiple therapeutic areas using the client's tools, systems, guidelines, templates, and processes.
The ICW will be required to demonstrate the following competencies:

Scientific knowledge / Health literacy

• Understanding the structure of protocols 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 the design, objectives, and activities of a clinical trial for a non-specialist audience, using established guidelines and government regulations, in a clear, concise, and health-literacy-friendly format.

• Knowledge of the relevant International Council on Harmonisation (ICH) guidelines and regulatory requirements relating to informed consent

Technological skills

• Technical expertise in MS Office tools (Word, Excel, Project) and Adobe Acrobat

• Experience with document management systems and workflow management

• Experience with collaborative writing and proofreading tools

• Understanding of structured content management concepts

• Flexibility and ability to adapt to new tools and technologies

Other skills

• Ability to work in a fast-paced environment with strict deadlines, both independently and collaboratively with teams

• Complete mastery of reading and writing in American English

• Excellent communication skills (responding to emails, giving presentations in meetings)

• Strong time management, organizational, and interpersonal skills

• Orientation client

• Strong project management skills

Formation

• Degree in Life Sciences

• 3 to 5 years of relevant experience preferred, including demonstrated experience in translating scientific content for a non-specialist audience

Responsibilities

• Read and understand the design, objectives, and procedures specific to the protocols.

• Draft study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (where applicable), and the required risk-related language.

• Collaborating with protocol authors to ensure a complete understanding of protocol details and the approval timeline

• Drafting, editing, and proofreading informed consent documents in accordance with health literacy principles

• Manage informed consent drafting projects, including the design, planning, and preparation of documentation in support of clinical development

• Participate, as needed, in clinical trial team meetings to ensure the timely delivery of informed consent documents

• Resolving documentary issues related to informed consent

• Providing support to Global Clinical Trial Operations through its expertise in informed consent processes and specific study support

• Potentially participate in the integration and coaching of junior team members

• Participate potentially in initiatives aimed at improving medical writing processes and standards

• Support the development, improvement and testing of tools, as needed

• Ensure compliance with company training requirements and monitor working hours.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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, 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to 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.

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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.